MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP DHS-PL 135° 3HO L76 STANDBARREL TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.224.223S

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history record has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with the lcp dhs plate in question. During the surgery, the surgeon inserted the blade (length 70mm). The surgeon originally had to use a plate with shorter barrel, but she used the plate with the standard barrel. The plate was fixed, but the distance between the blade part and the barrel part was shorter than usual, because the surgeon used the standard barrel plate. The fracture was atypical, and there was a gap (about 1-2mm long) around the femur calcar. The surgeon commented that the cut-out will not occur because the plate will hardly slide. There was no surgical delay. No further information is available. This complaint involves two (2) devices. This report is for one (1) lcp dhs-pl 135° 3ho l76 standbarrel tan. This report is 1 of 2 for (b)(4).

• Brand Name: LCP DHS-PL 135° 3HO L76 STANDBARREL TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9120772
• MDR Text Key: 191977994
• Report Number: 8030965-2019-68707
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.224.223S
• Device Lot Number: 3L91202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown