MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDEWIRE Ø3.2 L400; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 357.399S

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information will be reported.Device is an instrument and is not implanted/explanted.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, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.

Event Description

It was reported that during surgery the surgeon tried to insert the femoral neck screw into the nail.The screw was catching in the insertion hole.The surgeon tried another screw, same size with same outcome.The surgeon switched and used a helical blade.This worked without problem.The surgeon thinks he was doing something wrong, a possible problem might be a bent guidewire.This was disposed of in sharps bin so they are no longer able to check.Concomitant reported parts: 1x unknown guidewire; 1x unknown nail.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Concomitant device update.Initial reporter: name, country code, and occupation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Concomitant device reported: 12mm 130 degree cannulated tfn nail 440mm-left (456.485s, lot l639325, quantity 1).

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.Mwr-20022018-0000060028 was submitted without a g4 date.Correct date should have been 2/20/2018.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 europe reports an event in great britain as follows: it was reported during a surgical procedure to implant the trochanteric fixation nail (tfn) system on january 14, 2018, surgeon was not able to insert the femoral neck screw into the nail, as the screw was catching on the insertion hole.Surgeon then attempted with another screw of the same size but received the same results.Surgeon then opted to use the helical blade instead of the screw.The helical blade was inserted with no problem.Surgery was completed successfully with a delay of approximately 10 minutes.Concomitant devices reported: 12mm 130 degree cannulated tfn nail 440mm-left (456.485s, lot l639325, quantity 1) this report is for one (1) 3.2mm guide wire 400mm this is report 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.Dhr review was completed.Part: 357.399s lot: l708024 manufacturing site: selzach supplier: früh verpackungstechnik ag release to warehouse date: 22.Dec.2017 expiry date: 01.Dec.2027 part was only packed and sterilized at synthes gmbh and as this complaint is neither packaging nor sterilization related no review of these documents is necessary.Dhr review for unsterile part 357.399 with lot h514992: part number: 357.399 lot number: h514992 part manufacturing date: 1 december 2017 manufacturing site: elmira part expiration date: n/a nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies.The device history record shows lot h514992 of 3.2mm guide wires was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lot h489349 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h430617 met all specifications with no issues documented that would contribute to this complaint condition.H11 corrected data: b5, d11: event description, concomitant devices 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: GUIDEWIRE Ø3.2 L400
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7252743
• MDR Text Key: 99803887
• Report Number: 8030965-2018-50967
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819384194
• UDI-Public: (01)07611819384194(17)271201(10)L708024
• 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,Followup,Followup
• Report Date: 01/18/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 357.399S
• Device Lot Number: L708024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 01/18/2018; 03/20/2018; 04/09/2018
• Supplement Dates FDA Received: 03/19/2018; 03/20/2018; 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1