MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 7H/LEFT/125MM; PLATE, FIXATION, BONE

Catalog Number 04.112.145

Device Problems Nonstandard Device (1420); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional pro code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.A device history record review has been requested.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 (b)(6) reports an event as follows: it was reported that during an unknown procedure on an unknown date, a titanium (ti) locking compression plate (lcp) distal fibula plate was noted to have no screw thread.The plate was changed to another one to complete the procedure.There was no adverse consequence to the patient.This report is for a 2.7mm/3.5mm ti lcp lateral distal fibula plate.This is report 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.H10 additional narrative: h3, h6: part: 04.112.145; lot: h141281; manufacture date: july 15, 2016; manufacture location: elmira synthes usa; expiration date: n/a; noted nonconformances: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm ti lcp lat distal fibula product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Product will not be received for investigation, but three photos were provided.Investigation site: elmira synthes usa.The visual inspection performed on the provided photos confirms the complaint condition of missing threads as there is no visual presence of threads in the dlh holes (dlh1-dlh5).Relevant actions have been taken to address the issue.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: 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 7H/LEFT/125MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8061719
• MDR Text Key: 127217633
• Report Number: 8030965-2018-58118
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819382855
• UDI-Public: (01)07611819382855
• Combination Product (y/n): N
• PMA/PMN Number: K083213
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.112.145
• Device Lot Number: H141281
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Patient Sequence Number: 1