MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM F/EXPERT HAN F/03.008.007; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.008.009
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, intraoperatively the aiming arm could not be used correctly, the aim was inaccurate.Three bolts should be placed during the ankle joint surgery but only one could be placed due to the allegation of the instrument.Procedure was delayed for sixty(60) minutes.This report is for one (1) aim-arm f/expert han f/03.008.007.This is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.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
It was also reported that aiming arm shows damage and the drill bit has been blunted.Surgery was completed with the reported device.Patient outcome is reported as good.
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: d4: lot d9 h3, h4, h6: part: 03.008.009 lot: 1842864 manufacturing site: hagendorf supplier: n/a release to warehouse date: april 24, 2008 expiration date: n/a a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 the aim-arm f/expert han f/03.008.007 ( 03.008.009) is in used conditions, some scratches and signs of damage are present on the device, however; the device it looks able to function properly.In addition, due to all the mating parts were not received (the aiming arm, the bolts, the plate/nail), we are unable to confirm that the aim is inaccurate.A dimensional inspection for the aim-arm f/expert han f/03.008.007 was unable to be performed due to due to basic dimension are irrelevant to the complaint condition.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 aim-arm f/expert han f/03.008.007 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.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: AIM-ARM F/EXPERT HAN F/03.008.007
• Common Device Name: GUIDE, 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13358961
• Report Number: 8030965-2022-00544
• Device Sequence Number: 11923740
• Product Code: FZX
• UDI-Device Identifier: 07611819331075
• UDI-Public: (01)07611819331075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,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 Catalogue Number: 03.008.009
• Device Lot Number: 1842864
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/08/2022; 03/08/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/04/2022; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2008
• 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: AIMING ADAPTER F/EXPERT HAN F/03.008.009; DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0; UNK BOLTS
• Patient Age: 50 YR
• Patient Sex: Male