MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI RECONSTRUCTION PLATE . 10 HOLES/118MM; APPLIANCE,FIXATION,SPINAL INTERLAMINAL

Catalog Number 445.33

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Pma/510k: device is not distributed in the united states but is similar to device marketed in the usa.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) 2020, the patient underwent open reduction internal fixation surgery for pelvic fracture.During the surgery, the surgeon bent the plate.When bent the plate slightly again, the plate cracked at the third hole from the edge.The surgeon used another plate instead, and the surgery was completed successfully.The surgical delay was unknown.The patient outcome was unknown.Concomitant device reported: unknown plate bender (part# unknown, lot# unknown, quantity# 1).This is report 01 of 01 of (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.H3, h6: part number: 445.330s; lot number: l552814; manufacturing site: selzach; supplier: (b)(4); release to warehouse date: 01.Sep.2017; expiry date: 01.Aug.2027.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 445.330 with lot l525914 were reviewed: part number: 445.330; lot number: l525914; manufacturing site: raron; release to warehouse date: 11.Aug.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the received lcp reconstruction plate 3.5, curved, 12 holes is cracked at the 10th hole from the side with the laser marking.It is clearly visible that the plate was bent downward in the fracture area before it cracked.The rest of the plate is bend in different directions for contouring, there are all over the plate clearly visible deep nicks from a bending tool.The anodized layer is worn away at these marks which indicates that they were caused post-manufacturing.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.Therefore, another section (9th intact hole) close to the cracked area was measured.Checked dimensions per drawing: plate width = pass; plate thickness = pass; hole diameter = pass.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.A review of the raw material certificate as part of the dhr review was done.The certificate does confirm that the plate was made out of unalloyed titanium grade 4 per iso norm 5832-2 for implants for surgery.Investigation conclusion: the complaint is confirmed as the received plate is cracked as complained.During the performed evaluation no manufacturing related issue could be detected.This lot of (b)(4) pieces was manufactured in august 2017, all devices are distributed, and we are not aware of any other complaint for this article- and lot combination.Based on the provided information we are not able to determine the exact cause of this crack.There was no information provided which bending tool was used, also how the tool was used is unknown.The several very deep nicks in a short distance next to the crack indicate that the plate was exposed to high forces in this area.Also there are deep nicks on both sides of the plate in the fracture area, while on other contoured places the nicks are only on one side.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance.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 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: 3.5MM TI RECONSTRUCTION PLATE . 10 HOLES/118MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERLAMINAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9752319
• MDR Text Key: 190480246
• Report Number: 8030965-2020-01408
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 07611819219762
• UDI-Public: (01)07611819219762
• Combination Product (y/n): N
• PMA/PMN Number: K982322
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 445.33
• Device Lot Number: L525914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/03/2020
• Patient Sequence Number: 1
• Treatment: PELVRECO-PL3.5 CURV 12HO L142 TI; UNK - BENDING INSTRUMENTS