MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM CANNULATED CONICAL SCREW 80MM; SCREW, FIXATION, BONE

Model Number	02.205.280
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient underwent the removal of osteosynthesis material and a condylar support plate that had failed.The distal locking screws of the plate were loose and one was already exposed outside of the skin.An additional reduction was performed but the screws did not block the plate and it was decided to remove all the material and put a splint in one of the wounds that was found to be infected.The first intervention was performed because the distal screws of the plate came off.The second operation was performed to extract a screw that was exposed through the skin and the third intervention was when all of the material was removed.The first two interventions were performed to remove the implant and try to correct the new fracture, in the last surgery it was shown that there was an infection.This report is for one (1) 5.0mm cannulated conical screw 80mm.This is report 2 of 9 for (b)(4).This report is linked to (b)(4).
Additional 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.H3, h4, h6 investigation summary 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 history part number: 02.205.280, 5.0mm cannulated conical screw 80mm, lot number: 3l20230 (non-sterile), manufacturing location: monument , manufacturing date: 24-may-2019, lot quantity: 91.Four pieces were scrapped in cell at op #20, gundrill, after a functional failure.One piece was scrapped in cell at op #30, mill threads, after a machine malfunction.Production order traveler met all inspection acceptance criteria apart from the five pieces noted.Inspection sheet, inspect turn/wobble broach/inspect gun drill/inspect mill threads/inspect grind flutes/final inspection, met all inspection acceptance criteria apart from the four pieces noted.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Component part(s) reviewed: part number: 11222, 316l**ri8.50, lot number: h728604, lot quantity: 1,844 lbs.Certificate of tests supplied by carpenter dated 20-aug-2018 was reviewed and determined to be conforming.Lot summary report dated 31-aug-2018 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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: 5.0MM CANNULATED CONICAL SCREW 80MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10312557
• Report Number: 8030965-2020-05180
• Device Sequence Number: 3162827
• Product Code: HWC
• UDI-Device Identifier: 10886982050007
• UDI-Public: 10886982050007
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 02.205.280
• Device Catalogue Number: 02.205.280
• Device Lot Number: 3L20230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention