MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS; EXTRACTOR

Catalog Number	309.069
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 309.069.Lot: 7980646.Manufacturing site: (b)(4).Release to warehouse date: 08.Aug.2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a removal surgery for tomofix plate due to bone union.The implant had been in patient body for about 3 years.During screw removal, the screw broke at its neck.The surgeon used the extraction bolt after reaming with hollow reamer.However, the bolt did not hold the broken screw and he could not remove it.Two (2) broken screws were left in the patient's body.The second and third screws from the distal side of the plate were broken.The surgery was delayed by less than thirty (30) minutes.There is no plan to perform re-operation currently.No further information is available.Concomitant devices reported: unknown plate (part #: unknown, lot #: unknown, quantity #: 1), unknown hollow reamer (part #: unknown, lot #: unknown, quantity #: 1).This report is for one (1).Extraction bolt for 6.5 mm & 7.0 mm screws.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
Concomitant devices reported: unknown plate (part #: unknown, lot #: unknown, quantity #: 1), unknown hollow reamer (part #: unknown, lot #: unknown, quantity #: 1); unknown screw (part #: unknown, lot #: unknown, quantity #: 1).
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.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: EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9118782
• Report Number: 8030965-2019-68678
• Device Sequence Number: 1924533
• Product Code: HWB
• UDI-Device Identifier: 07611819056527
• UDI-Public: (01)07611819056527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309.069
• Device Lot Number: 7980646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: TOMOFIX OSTEOTOMY; UNK - PLATES: TOMOFIX OSTEOTOMY; UNK - REAMERS; UNK - REAMERS; UNK - SCREWS: TRAUMA; UNK - PLATES: TOMOFIX OSTEOTOMY; UNK - REAMERS