MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAMER TUBE FOR HOLLOW REAMER

Catalog Number	309.068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that this pc is related to (b)(4), which reports the broken nail, (b)(4) which reports about the broken screws after the first reoperation in (b)(4), which reports about the breakage of the plate after the second reoperation in (b)(4).This pc reports about the breakage of the screws and hollow reamer in the third reoperation.It was reported that on (b)(6) 2019, the first reoperation was performed.On (b)(6) 2019, the second reoperation was performed due to breakage of the screws, and in the second surgery, the surgeon implanted 6 screws in question.On (b)(6) 2020, the third reoperation was performed due to breakage of the plate (reported by (b)(6)).During the third reoperation, a few screws of the 6 screws were worn, and a few screws of the 6 screws broke.The surgeon removed them with the hollow reamer and a carbide drill.The hollow reamer broke in the surgery.No further information is available.This report is for one (1) spare reamer tube for hollow reamer (309.065).This report is 1 of 7 for (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.E1: reporter is a synthes employee.H6: part: 309.068 (36598), lot: 9228379, manufacturing site: bettlach, release to warehouse date: 15.Jan.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Reviewing attached picture, the breakage of the device can be confirmed.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
Concomitant device reported: unknown carbide drill (part #: unknown, lot # unknown, quantity 1), unknown plate (part #: unknown, lot # unknown, quantity 1).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.E1: reporters state: (b)(6).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: SPARE REAMER TUBE FOR HOLLOW REAMER
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9684671
• Report Number: 8030965-2020-00983
• Device Sequence Number: 11463075
• Product Code: HTO
• UDI-Device Identifier: 07611819201873
• UDI-Public: (01)07611819201873
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2020

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: 309.068
• Device Lot Number: 9228379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 03/12/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/09/2020; 04/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CARBIDE DRILL; UNK - CARBIDE DRILL; UNK - PLATES; UNK - PLATES