MAUDE Adverse Event Report: SYNTHES GMBH COUPLING BOLT LCP PERIARTICULAR AIM ARMS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.120.030
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, during a case, the surgeon was using an aiming arm, but it did not work.It was not connecting to the two pieces and is a bolt connecting bolt for the aiming arm of the periartic aim arm instrument that connects both pieces together.It was unknown if there were any patient consequences or outcomes.This report is for one (1)coupling bolt lcp periarticular aim arms this is report 3 of 3 (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The product was not returned to depuy synthes, however photos were provided for review.The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.G1, h3, h4, h6: part 03.012.030, lot 1997871: release to warehouse date: october 09, 2008.Manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.Devices involved in this complaint connect-bolt f/aiming arm f/periarti-aim (03.120.030), insertion handle f/aiming arm f/lcp prox (03.120.002) and aim-arm f/lcp prox-tib-pl4.5/5 r (03.120.001) were sent to manufacturer to perform further investigation with the following results: visual inspection was performed, and items was received in used conditions showing evidence of use.Visual inspection also found the threads on the insertion handle were damaged.A functional test was performed, the coupling bolt (03.120.030) is threaded in the proximal end of the aiming arm (03.120.001) and there are no issues identified.Coupling bolt passed through the m6 thread in the proximal end of the aiming arm.The coupling bolt (03.120.030) was threaded in the handle (03.120.002) and no issues were identified.The coupling bolt is fully threaded in the m6 thread in the handle.The aiming arm (03.120.001), handle (03.120.002) and the coupling bolt (03.120.030) were assembled per the surgical technique guide and the coupling bolt was not able to hold the handle component with the aiming arm due to the damaged threads.A dimensional inspection was conducted on device reported and it was identified that features are within the specification and tolerance range specified in the drawing.Based on dhr, the manufacturing process was executed according to the corresponding documents.The device allegation was not confirmed as the observed condition of the coupling bolt lcp periarticular aim arms would not contribute to the reported event as the defect is related to the mating device periart insrt hndl 4.5 lcp prx tib pl-rt (03.120.002) based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): product code: : 03.012.030.Lot number : 1997871.Release to warehouse date : 09 oct 2008.Expiration date : na.Supplier: na.Manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Corrected data: d4: udi updated.The expiration date is currently not available.Additionally, the serial number for the device involved in the event was not provided; therefore, the full udi is currently not available.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COUPLING BOLT LCP PERIARTICULAR AIM ARMS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18566776
• Report Number: 8030965-2024-01262
• Device Sequence Number: 20498320
• Product Code: LXH
• UDI-Device Identifier: 10886982074270
• UDI-Public: (01)10886982074270(11)081009(10)1997871
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.120.030
• Device Lot Number: 1997871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 01/24/2024; 02/13/2024; 04/30/2024; 07/02/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/06/2024; 02/27/2024; 05/10/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PERIART INSRT HNDL 4.5 LCP PRX TIB PL-RT; PERIARTIC AIM ARM 4.5 LCP PROX TIB PL-RT
• Patient Sex: Unknown