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

Catalog Number 03.037.113

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the aiming arm didn't fit well with the system.Concomitant device reported: tfna femoral nail: (part# 04.037.142s; lot# 54p3309; quantity: 1).Tfna screw (part# 04.038.210s; lot# h090596; quantity: 1).This report is for one (1) aim-arm 130° f/stat+dyn dist lock.This is report 1 of 1 for (b)(4).

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: part # 03.037.113, lot # l297231, manufacturing site: oberdorf, release to warehouse date: april 13, 2017, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: cap inserter (p/n: 277040700, lot #:t0304) was returned and received at us customer quality (cq).Upon visual inspection, no issues were observed with the returned device.Device failure/defect identified? no.Document/specification review the following drawing, reflecting current and manufactured revisions were reviewed: aiming arm tfna 130 - asm- transverse no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion the complaint was not confirmed for the returned devices.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.

• Brand Name: AIM-ARM 130° F/STAT+DYN DIST LOCK
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12675047
• MDR Text Key: 277730799
• Report Number: 8030965-2021-08873
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.113
• Device Lot Number: L297231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 130° L170 TIMO15; TFNA SCR PERF L110 TAN; TFNA FEM NAIL Ø11 130° L170 TIMO15; TFNA SCR PERF L110 TAN
• Patient Sex: Male