MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 02.224.204S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a left pertrochanteric fracture requiring dhs-type surgical management, the screw did not insert into the plate.The issue was identified during the preoperative room assembly test.The plate and screw were replaced.There was no patient consequence.This report involves one (1) 130 deg lcp dhs plate-standard barrel 4 holes/92 mm-sterile.This is report 2 of 2 for (b)(4).This product complaint, (b)(4), is related to (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.G5: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection has shown that the plate is intact and in general in a very good condition, there are no damages at the screw interface visible.Investigation conclusion: the complaint is confirmed as it is impossible to assemble the received plate and screw as complained.The cause of this malfunction can be clearly traced back to a deformation at the screw.There is no indication that the plate did contribute to complained malfunction.The root cause was identified during the performed cq evaluation of the also received dhs/dcs screw and therefore the in the investigation flow listed remaining investigation steps are not required for the plate.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 02.224.204s, lot: 3l19510, manufacturing site: grenchen, release to warehouse date: 08.Mar.2019, expiry date: 01.Feb.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: 130 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10153172
• MDR Text Key: 195113329
• Report Number: 8030965-2020-04151
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819820982
• UDI-Public: (01)07611819820982
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.224.204S
• Device Lot Number: 3L19510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 06/16/2020
• Patient Sequence Number: 1