MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; PLATE,FIXATION,BONE

Catalog Number 04.211.020S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 09/27/2021

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, the patient underwent an osteosynthesis surgery for the distal end of humerus fracture.During the surgery the locking screw couldn¿t be locked, so the surgeon the locking screw couldn¿t be attached to the plate.The surgeon commented that the plate might has been scraped because the surgeon performed drilling while the drill guide was not firmly fixed to the plate.The surgery was completed successfully within 30 minutes delay.Concomitant device reported: unk - screwdriver: (part# unknown; lot# unknown; quantity: unknown) unk - drill (part# unknown; lot# unknown; quantity: unknown) unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 20mm.This is report 1 of 2 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 the threads of va lockscr ø2.7 head 2.4 self-tap l20 ta head was deformed and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The functional test cannot be performed due to the absence of plate.However the deformed threads of the screw head could have caused the screw to not lock appropriately with the plate.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 ø2.7 head 2.4 self-tap l20 ta.While no definitive root cause could be determined, the locking screw would have undermine unintended forces that caused the threads to deformed.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.Device history lot: part # 04.211.020s; lot # 8l38265; release to warehouse date: 22 july 2021; expiration date: 01 july 2031; supplier: (b)(4).Non-sterile: part # 04.211.020; lot # 231p765.Manufacturing location: monument; manufacturing date: 16-jun-2021; part number: 04.211.020, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 20mm; lot number: 231p765 (non-sterile); lot quantity: (b)(4).One piece was scrapped in cell at op #20, turn/thread head, flute, after a robot misload.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final inspection, ns049907 rev p met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad 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: component parts were not reviewed as the reported complaint condition of ¿surgeon couldn¿t attach the locking screw to the plate¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: 05-oct-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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12683439
• MDR Text Key: 278139694
• Report Number: 8030965-2021-08902
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.020S
• Device Lot Number: 8L38265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - DRILL.; UNK - GUIDES/SLEEVES/AIMING: GUIDE.; UNK - PLATES: 3.5 MM LCP DISTAL HUMERUS PLATE.; UNK - SCREWDRIVERS.