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 Codes	Device Slipped (1584); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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)(4) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for femoral neck fracture (ao classification 31b1) with fns.The surgeon used protection sleeve (03.023.002) in reaming.However, the drill bit penetrated the bone head because the nut was detached from the reamer.The surgeon continued the surgery and inserted the bolt, antirotation-screw and the plate with locking screw.The surgery was completed with no delay.The surgeon commented that he over-reamed because the nut of the reamer had been loosed and detached.No further information is available.Concomitant device reported: protection sleeve (part # 03.023.002, lot # unknown, quantity # 1).This report is for one (1) nut for reamer.This complaint involves three (3) devices.This report is 1 of 3 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.H3, h4, h6: the article 03.168.007 with lot f-21958 is a semi-finished part and got sold as article 03.168.004 with lot f-22746.Part: 03.168.004, lot: f-22746, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 14.Jul.2017.A manufacturing record evaluation (mre) is not required, as the part is fully functional, and as we are not able to reproduce or confirm this incident.Visual inspection: upon visual inspection of the complaint device it can be seen that the outer diameter (handle) is deformed, the damage resulted most likely from loosen the nut with an instrument like a pliers.Otherwise, the part is in a good condition.Functional test: during investigation a functional test was performed.The three parts together (drill bit, reamer and nut) passed the functional test.Summary: unfortunately, we are not able to reproduce this incident or to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place.To prevent such problems, it is necessary worn, incomplete or damaged instruments to replace and/or to operate according to the technique guide.We are not able to reproduce or confirm this incident, as the part is fully functional, therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: patient code 3191 used to capture bone injury.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: 9715427
• Report Number: 8030965-2020-01166
• Device Sequence Number: 3128941
• 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
• Report Date (Section B): 01/23/2020

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 Catalogue Number: 03.168.007
• Device Lot Number: F-21958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/16/2020
• Supplement Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROTECT SLEEVE 20/17 F/PFNA-II
• Outcome Attributed to Adverse Event: Required Intervention