MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH NUT FOR REAMER COMPONENT OF THE 03.168.004; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	03.168.007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.A review of the device history records 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, an open reduction internal fixation was applied during a surgery for a femoral neck fracture.While the surgeon was reaming the bonehead with the reamer, he noticed that the nut had come off the drill bit in question.The surgeon removed the reamer from the bone; then, he tried to disassemble it.However, the nut and the reamer portion cracked, and he could not remove them from the drill bit.The surgery was completed with a thirty (30) minute delay.There was no adverse consequence to the patient.After the surgery, it was tried again to disassemble the reamer, but it could not be done manually.After hammering the drill bit, disassembling the reamer was successful.This report is for a nut.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 03.168.00, lot: f-22798.Manufacturing location: selzach, release to warehouse date: nov 20, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformity noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and confirmed to be correct per the specification with no non-conformance noted.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.H3, h6: product investigation was completed.The nut for reamer is intact nothing is broken off or cracked but is covered with nicks and marks of inappropriate use.As the nut was blocked on the drill bit it is not possible that it fell apart first.Furthermore, nothing has cracked on all the three complained components.The visible outside damage was caused during hammering on the device as per event description.The use related damage on the reamer 03.168.006 has been identified as root cause for the inability to disassemble the three component devices as per event description.The complaint determination for this device can be confirmed for the unable to disassemble but not for cracked and falling apart.During the evaluation the root cause was identified as event related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: NUT FOR REAMER COMPONENT OF THE 03.168.004
• Common Device Name: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8223348
• Report Number: 8030965-2019-59522
• Device Sequence Number: 1656693
• Product Code: HWE
• UDI-Device Identifier: 07611819657335
• UDI-Public: (01)07611819657335
• 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,Followup
• Report Date (Section B): 12/12/2018

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: 03.168.007
• Device Lot Number: F-22798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 02/18/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/25/2019; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1