MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP METAPHYSEAL PLATE 8 HOLES; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Catalog Number 423.408S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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) 2016, the patient underwent the surgery for ulna fractures at another hospital by using the lcp metaphyseal plates 3.5.On (b)(6) 2020, the patient felt a pain when moving his/her arm.It was confirmed that the patient had a suspected atypical fracture and the plate had been broken.On (b)(6) 2020, the patient underwent the revision surgery where the fixation by lcp (small) implant and bone graft were applied to the patient.The patient is taking the bisphosphonate and has been under follow-up since 2018 at (b)(6).No further information is available.This report is for one (1) 3.5mm ti lcp® metaphyseal plate 8 holes.This is report 2 of 2 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.H6: part number: 423.408s, lot number: 9906349, manufacturing site: grenchen, release to warehouse date: 19.April 2016, expiry date: 01.April 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 3.5MM TI LCP METAPHYSEAL PLATE 8 HOLES
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10489146
• MDR Text Key: 212385178
• Report Number: 8030965-2020-06594
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 07611819282698
• UDI-Public: (01)07611819282698
• Combination Product (y/n): N
• PMA/PMN Number: K033805
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423.408S
• Device Lot Number: 9906349
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention