MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI NARROW LCP® PLATE 9 HOLES/170MM; PLATE, FIXATION, BONE

Catalog Number 424.591S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Additional product codes hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, open reduction internal fixation surgery for the femoral diaphyseal fracture was performed with the plate in question.During the surgery, the surgeon could not attach the lcp drill sleeve to the plate properly.Cortex screws were used instead of locking screws because the sleeve could not be used.The surgery was delayed by less than 30 minutes.After the surgery, the surgeon and the sales rep confirmed the sleeve had no problem by attaching it to another plate.It was found by x-rays that the plate was implanted reversely.It was noted the fixation was obtained firmly and the patient is inactive due to her disorder.Concomitant device reported:  lcp drill sleeve (part# 323.042, lot # unknown, quantity 1).Unknown locking screws (part/lot# unknown, quantity unknown).This is report 1 of 1 for (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.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

Concomitant device reported: lcp drill sleeve (part# 323.042, lot # unknown, quantity 1), unknown screws cortex (part# unknown, lot # unknown, quantity 1).

• Brand Name: 4.5MM TI NARROW LCP® PLATE 9 HOLES/170MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8868712
• MDR Text Key: 153505393
• Report Number: 8030965-2019-66924
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819260177
• UDI-Public: (01)07611819260177
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 424.591S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 09/05/2019
• Patient Sequence Number: 1
• Treatment: LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3; LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention