MAUDE Adverse Event Report: SYNTHES GMBH STANDARD INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.045
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.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.
Event or Problem Description
Device report from colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2023, the lfn nail was mounted to the insertion arc and delivered to the surgeon.When the surgeon began to introduce the nail into the femoral canal with a hammer, it was noticed that the nail of the insertion arc had loosened.The surgeon was unable to tighten the nail with a ball screwdriver and pass the broc.It was found that the nail was released from the insertion arch because the connection notch had broken.Because of this, the drill bit split when it collided with the nail.Distal interlocks were made using another drill but, but the drill bit bent in the bore.The surgery was completed successfully.This report is for a standard insertion handle.This is report 1 of 3 for (b)(4).
Event or Problem Description
It was further reported that the broken fragment was retained in the patient.
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.H6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that insert-handle f/expert tn+fn was found with scratches, indentations, and deformations are present all over the device.In addition, the guide hole was observed distorted in shape.Most likely the device has incurred an impact on the indicated location during usage.Multiple indentations and deformations are observed on the part.Assembling issues are most likely due to this condition.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test was unable to be performed due to mating device was not received.However; based on the damage observed it is reasonable that the observed condition prevents the insert-handle f/expert tn+fn from assembling its mating device as intended, therefore the reported allegation can be confirmed.The overall complaint was confirmed as the observed condition of the insert-handle f/expert tn+fn would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part number: 03.010.045; lot number: 18p9769; manufacturing site: haegendorf; release to warehouse date: 28.11.2019.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the insert-handle f/expert tn+fn [03.010.045/18p9769].There is not enough evidence in the photo to confirm the allegation.Functionality issues cannot be assessed through a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the insert-handle f/expert tn+fn [03.010.045/18p9769] was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STANDARD INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17239019
• Report Number: 8030965-2023-08211
• Device Sequence Number: 7063569
• Product Code: LXH
• UDI-Device Identifier: 10886982067173
• UDI-Public: (01)10886982067173
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: 03.010.045
• Device Catalogue Number: 03.010.045
• Device Lot Number: 18P9769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 09/04/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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: 13 TI LFN RECON NAIL-EX/380/RT.; UNK - DRILL BITS: TRAUMA.; UNK - DRILL BITS: TRAUMA.
• Patient Sex: Unknown