MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 20 HOLES; APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM

Catalog Number 224.765S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This patient information is unknown.Date of postoperative plate breakage is unknown.Implanted on an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that a patient had a cancer removed from the femur and subsequently has had autograft and allograft to fill the void and was implanted with a locking compression (lcp) metaphyseal plate on an unknown date in (b)(6) 2018.The challenge was to get the graft to integrate with patient¿s bone.Unfortunately, that did not happen, as the metaphyseal plate broke before that.Therefore, surgeon decided to implant the stronger construct.Patient was revised on (b)(6) 2018 with a curved broad plate.Patient outcome reported as no adverse effect.This report is for one (1) 4.5mm/3.5mm lcp metaphyseal plate 20 holes.This is report 1 of 1 for complaint (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.Part: 224.765s; lot: 2666516; manufacturing site: bettlach; release to warehouse date: november 22, 2010; expiry date: november 01, 2020 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Complaint is confirmed as we are able to confirm complaint description based on the received pictures.Product was not returned.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.

• Brand Name: 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 20 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: 7641617
• MDR Text Key: 112455712
• Report Number: 8030965-2018-54659
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 07611819282469
• UDI-Public: (01)07611819282469
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 224.765S
• Device Lot Number: 2666516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 08/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR