MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L14 TA; PLATE,FIXATION,BONE

Catalog Number 04.211.014S

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: hwc.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) va lockscr ø2.7 head 2.4 self-tap l14 ta.This report is 3 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 va lockscr 2.7 head 2.4 self-tap l14 ta the threads of the screw were stripped at the neck and the hex is also deformed.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of va lockscr 2.7 head 2.4 self-tap l14 ta 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 va lockscr 2.7 head 2.4 self-tap l14 ta.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 # 04.211.014s , lot # 8l11121 , manufacturing site: selzach, release to warehouse date: apr 26, 2021, expiration date: apr 01, 2031, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.014, non-sterile lot # 97p5671.Manufacturing location: monument, manufacturing date: mar 26, 2021, part number: 04.211.014, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 14mm, lot number: 97p5671 (non-sterile), lot quantity: (b)(4).Four pieces were scrapped in cell at op #10, mill shaft threads, after a robot misload.One piece was scrapped in cell at op #60, anodize, after being dropped.Production order traveler met all inspection acceptance criteria apart from the five pieces noted.Inspection sheet, in process / inspect dimensional / final inspection, ns049907 rev n met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.211.014.999, 2.8mm ti screw blank 14mm 2.7 variable angle w/sd8, lot number: 87p0824, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect warm head blank/inspect turn head and point, ns072130 met all inspection acceptance criteria.Device history review aug 11, 2021: dhr reviewed.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: VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L14 TA
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12177844
• MDR Text Key: 261911353
• Report Number: 8030965-2021-05808
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819425231
• UDI-Public: (01)07611819425231
• 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
• 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: 04.211.014S
• Device Lot Number: 8L11121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 08/12/2021
• Patient Sequence Number: 1
• Treatment: SCRDRIVER SHAFT 2.4 SHORT SELF-HOLD; SCRDRIVER SHAFT T8 SELF-HOLD; SCRDRIVER SHAFT T8 SELF-HOLD; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA