MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP DHS-PL 135° 4HO L92 STANDBARREL SST; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 02.224.224S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during implanting the lag screw, it did not fit into the dynamic hip plate (dhs).The customer took out the lag screw and tested it on a new plate.It appeared that the problem was the lag screw because it didn't fit.There was a 20 minute delay but no harm to patient.Procedure; proximal femur / hip fracture using dynamic hip system (dhs).This complaint involves one (1) lcp dhs plate.This report is 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.The initial complaint was reviewed and found not reportable.This event was re-reviewed due to additional information received.Two plates were used during the procedure.The first which the lag screw would not fit and the 2nd was used to check whether it was the lag screw or plate which was causing the problem.The first plate remains in the patient along with the the replacement lag screw, the procedure was successfully completed.The second plate was returned.There is no allegation of a product malfunction or ae against the dhs plate.The issue is against the lag screw.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: LCP DHS-PL 135° 4HO L92 STANDBARREL SST
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7910435
• MDR Text Key: 121860942
• Report Number: 8030965-2018-56678
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819821217
• UDI-Public: (01)07611819821217
• Combination Product (y/n): N
• 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: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.224.224S
• Device Lot Number: L832015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 10/09/2018
• Patient Sequence Number: 1