MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)

Catalog Number	309.038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a surgery for distal tibia with the locking screws.On an unknown date, the surgeon found that one screw had been broken.On (b)(6) 2020, the patient underwent a removal surgery with the hollow reamer due to the screw breakage.During the surgery, the surgeon found that the other 2-screws had been broken and he had difficulty in removing the broken screw with the hollow reamer because the patient¿s bone quality was good.He tried many times, and when he pressured the reamer axially, the tip of the reamer broke.He removed the fragment of the broken reamer, but the fragment of the screws remained in the patient.He completed the surgery with another hollow reamer within 30 minutes delay.The total of the broken screws is 3.The patient outcome was unknown.Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity # 1), spare centering pin (part # 309.370, lot # unknown, quantity # 1).This complaint involves two (2) devices.This is 2 of 2 for report (b)(4).(b)(4).
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.E3: additional reporter.H3, h4, h6: a review of the device history record.Device history lot; part: 309.038 (sub-component 36599); lot: 7736300; manufacturing site: bettlach; release to warehouse date: 07.March 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary investigation selection: investigation site: cq zuchwil.Selected flow: damaged.Visual investigation: the spare reamer tube and the hollow reamer shaft are returned in a jammed condition.The visual inspection has shown that the forefront of the spare reamer tube is broken off and only one tooth is remaining.The cutting edges on the broken off piece are in a very used condition.Dimensional inspection: because of the damage and jammed condition, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The used material was stainless steel as required and the measured harness was within the specification.Summary: the received condition of the complaint agrees with the complaint description since the spare reamer tube is broken as claimed by the customer.Thus, the complaint is rated as confirmed.Based on the received information and as already the surgeon commented, we only can assume that a mechanical overloading situation during use has caused the breakage and consequently also the jamming of the devices.Insertion angle issues or not exactly following the surgical technique could have led to the mentioned issue.The hollow reamer and the extraction bolt are left-turning (to be turned anticlockwise).During insertion ensure that enough axial pressure is exerted and maintain the axis.Only use instruments with sharp edges.It is possible to use the hollow reamer with power tools, but this should be done very carefully.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 (309.035)
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9837254
• Report Number: 8030965-2020-01979
• Device Sequence Number: 1299782
• Product Code: HTO
• UDI-Device Identifier: 07611819201866
• UDI-Public: (01)07611819201866
• 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): 02/18/2020

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: 309.038
• Device Lot Number: 7736300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN; SPARECENTERPIN F/309.035; SPAREREAMERTUBE F/309.035; UNK - SCREWS: TRAUMA
• Patient Age: 38 YR