MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12.5MM REAMER COMPONENT OF THE 03.168.004; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 03.168.006

Device Problems Device Slipped (1584); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/23/2020

Event Type  Injury  

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 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) 12.5mm reamer component of the 03.168.004.This complaint involves three (3) devices.This report is 3 of 3 for (b)(4).

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 03.168.006 with lot f-22044 is a semi-finished part (42 pieces) and got sold as article 03.168.004 with lot f-22046 (39 pieces) and with lot f-23215 (3 pieces).Part: 03.168.004, lot: f-22046, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 10.Apr.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.Part: 03.168.004, lot: f-23215, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 01.Dec.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 cutting edges at the tip are worn from use.Otherwise, the part is in a used but 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: 12.5MM REAMER COMPONENT OF THE 03.168.004
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9715429
• MDR Text Key: 190332730
• Report Number: 8030965-2020-01170
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819657328
• UDI-Public: (01)07611819657328
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03.168.006
• Device Lot Number: F-22044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/16/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/10/2020
• Patient Sequence Number: 1
• Treatment: PROTECT SLEEVE 20/17 F/PFNA-II
• Patient Outcome(s): Required Intervention