MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER SHAFT 2.4 SHORT SELF-HOLD; PLATE,FIXATION,BONE

Catalog Number 314.453

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, the patient underwent open reduction internal fixation surgery for distal humerus fracture.During the surgery, when the surgeon tried to lock the 3 locking screws, the 3 locking screws got stripped and he couldn¿t lock them.The surgeon managed to remove the 3 locking screws and inserted new locking screws with another screwdriver without any problems.It was confirmed that there was no metallic debris left inside the body due to the locking screws being stripped.The surgery was completed successfully within 30 minutes delay.No further information is available.This complaint involves six (6) devices.This report is for (1) scrdriver shaft 2.4 short self-hold this report is 5 of 6 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that scrdriver shaft 2.4 short self-hold the tip of the screwdriver is deformed.No other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of scrdriver shaft 2.4 short self-hold in the device was consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for scrdriver shaft 2.4 short self-hold.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot 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.Drawing/specifications reviewed: related drawings are reflecting the current and manufacture revision was reviewed.Device history lot part # 314.453 , lot # l542632 , manufacturing site: hagendorf, release to warehouse date: oct 23, 2017.A manufacturing record evaluation was performed for the finished article lot 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: SCRDRIVER SHAFT 2.4 SHORT SELF-HOLD
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12177848
• MDR Text Key: 262199851
• Report Number: 8030965-2021-05814
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819831384
• UDI-Public: (01)07611819831384
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.453
• Device Lot Number: L542632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 08/24/2021
• Patient Sequence Number: 1