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

Catalog Number	03.037.113
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa.Part: 03.037.113.Lot: 2l65554.Manufacturing site: (b)(4).Release to warehouse date: february 08, 2019 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the aim-arm 130° f/stat+dyn dist lock was received at us customer quality (cq).The received photo was also reviewed.Visual inspection of the complaint device showed the device was missing component 9.No physical damage was observed.Functional test: during functional assessment, several attempts were made to insert the lock-insert f/aiming arm into the device but it couldn't advance fully and lock into position.Hence, functional assessment could not fully be performed.Dimensional inspection: no dimensional inspection was performed due to the nature of the complaint.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received missing the locking knob and was not able to be assembled with the insert.However, the jamming of the device was not able to be confirm.No root cause could definitively be determined for the reported complaint condition.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the guide sleeve was already hacked when it was inserted into the insertion handle.Placing the guide sleeve on the lateral cortex was difficult but worked.When the blade was driven in, the impact instrument of the helix blade did not drive forward properly.The impactor jammed.When trying to move the guide sleeve over the thread, it could no longer be moved in any direction.The complete construct (with all components of the insertion guide, trocar with compression nut, helix blade impactor) could hardly be moved and jammed.The helix blade could, therefore, not be placed properly in the femoral neck and came to rest with an overhang on the lateral cortex.The construct consisting of the guide sleeve and the aiming arm could no longer be loosened.The impact instrument could be removed from the trocar after loosening the connecting screw of the helix blade.In the steri, the remaining components could only be separated with the help of bone grasping forceps and the pin spanner.This resulted in notches on the guide sleeve.The procedure was completed with a (15) minute delay.This report is for an aiming arm.This is report 3 of 4 for (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.H10 additional narrative: a1.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
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12125862
• Report Number: 8030965-2021-05561
• Device Sequence Number: 4723192
• Product Code: HSB
• UDI-Device Identifier: 07611819642669
• UDI-Public: (01)07611819642669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 2L65554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUTTRESS/COMPR-NUT; GUIDE SLEEVE YELL; LOCK-INSERT F/AIMING ARM; PIN WRENCH Ø4.5 L120; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - HANDLES: TRAUMA; UNK - IMPACTION INSTRUMENTS: TRAUMA; UNK - INSERTION INSTRUMENTS; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING