MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Catalog Number 412.812S

Device Problem Defective Device (2588)

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

Event Date 04/11/2022

Event Type  malfunction  

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.Additional narrative: additional device product codes: hrs.Initial reporter facility name: (b)(6) hospital.Reporter is a j&j employee.Part#: 412.812s.Lot#: 301p168.Manufacturing site: (b)(4).Release to warehouse date: 19.August.2021.Expiry date: 01.August.2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Additionally, a visual inspection of the returned device was performed from the photo.Visual analysis of the returned sample revealed that the lockscr ø2.4 self-tap l12 tan was found to be stripped from both of the threaded sections of the screw.Photo evidence provided shows dark foreign material around the shaft and a string near the head of the screw.Nevertheless, signs of excess material cannot be seen from the returned device, therefore, burr condition cannot be confirmed.A dimensional inspection for the lockscr ø2.4 self-tap l12 tan was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the lockscr ø2.4 self-tap l12 tan would contribute to the complained device issue.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the surgery for the distal radius with the screw in question.In the surgery, the surgeon noticed a burr in the screw head.Since it was discovered during screw insertion when only the tip was being inserted, it was replaced with another product without patient's influence.The surgery was completed successfully without any surgical delay.This report involves one (1) 2.4mm ti locking scr slf-tpng with stardrive recess 12mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM
• Type of Device: SCREW, 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14933529
• MDR Text Key: 303426644
• Report Number: 8030965-2022-04584
• Device Sequence Number: 1
• Product Code: HWC
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.812S
• Device Lot Number: 301P168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA