MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR Ø3.5 SELF-TAP L30 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 412.111S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the returned locking screw head was forwarded to the manufacturing side for evaluation.The statement below is a summary of their investigation.As received condition, 6 screws have been returned (only the head screw was returned) unpacked and outside the original depuy synthes bag.The 6 broken screws correspond to the (b)(4).The screw is broken at the neck point and have strong traces of use on its surface.The laser mark is present and readable.The lot number on the complaint received corresponds to the lot number on the complaint part.The received condition of the article agrees with the complaint description since the screw is broken as claimed by the customer.Besides, the complaint is confirmed, since the available data supports the complainant¿s description of the complaint condition.However, from the manufacturing point of view, neither a defect nor a deficiency has been identified since no deviations were found in the documentation as well as during this investigation all relevant measurements performed are according to its specifications.Since no manufacturing issue was detected, no further actions have been taken.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 412.111s, lot: l385727, manufacturing site: grenchen, release to warehouse date: 02.May 2017, expiry date: 01.April 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.

Event Description

It was reported that on (b)(6) 2018, the patient underwent internal fixation surgery with the plate and the 6 locking screws in question.On (b)(6) 2019, the patient underwent removal surgery.During the removal surgery, the 6 locking screws broke at those necks.The surgeon removed the plate, but he didn¿t remove the 6 screw shafts, and he finished the surgery.The 6 screw shafts remained in the body.No further information is available.Concomitant devices reported: unknown plates: tibia (part# unknown, lot# unknown, quantity# 1) lcp med prox-tibpl 3.5 le shaft 6ho l119 (part# 439.957s, lot# h582399, quantity# 1).This complaint involves six (6) devices.This is 2 of 6 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found to be part of period summary reporting (psr) instead of individual 3500a reporting.This event will be captured on an upcoming quarterly summary 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.

• Brand Name: LOCKSCR Ø3.5 SELF-TAP L30 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9350070
• MDR Text Key: 191251272
• Report Number: 8030965-2019-70392
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819152083
• UDI-Public: (01)07611819152083
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.111S
• Device Lot Number: L385727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/21/2019
• Patient Sequence Number: 1