MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM 130 F/STAT+DYN DIST LOCK; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.113
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) ¿source file - novedad¿.The image(s) was reviewed, and the complaint condition could be confirmed since the knob had broken apart.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot - part: 03.037.113.Lot: 9705887.Manufacturing site: (b)(4).Release to warehouse date: 20.Nov.2015.A manufacturing record evaluation was performed for the finished device lot number, 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, while disassembling the arm for wash the knob snapped in two.This report is for one (1) aim-arm 130° f/stat+dyn dist lock.This is report 1 of 1 for complaint (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.Aim-arm 130° f/stat+dyn dist lock (p/n: 03.037.113, lot #: 9705887) was returned and received at us cq.Upon visual inspection, the knob on thumb screw of the device was observed to be broken.No other issues were observed with the returned device.The complaint condition is confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot: part: 03.037.113.Lot: 9705887.Manufacturing site: hägendorf.Release to warehouse date: 20.Nov.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part: 03.037.113.Lot: 9705887.Manufacturing site: hägendorf.Release to warehouse date: 20.Nov.2015.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: AIM-ARM 130 F/STAT+DYN DIST LOCK
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11937579
• Report Number: 8030965-2021-04579
• Device Sequence Number: 4176186
• Product Code: HSB
• UDI-Device Identifier: 07611819642669
• UDI-Public: (01)07611819642669
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 03.037.113
• Device Lot Number: 9705887
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1