MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1; WIRE, SURGICAL

Catalog Number 292.620S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.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.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)(6) as follows: it was reported that during an open reduction internal fixation (orif) procedure of the ankle on (b)(6) 2019, the 1.25 mm guide wire was broken while attempting to drill through with an unknown 2.7 mm cannulated drill bit.The surgeon have decided not to attempt to retrieve the wire.An unknown 3.5 mm cannulated screw was inserted over the wire.There was no injury or patient harm reported.It is unknown if there was a surgical delay.Surgical outcome is unknown.Concomitant device reported: unknown cannulated drill bit (part # unknown, lot # unknown, quantity unknown), unknown 3.5 mm cannulated screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) guidewire 1.25 w/thread-tip w/trocar l1.This is report 1 of 1 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.Common device name: additional device product code: hty.A device history record (dhr) review was conducted: part: 292.620s.Lot: 3l51497.Manufacturing site: selzach.Supplier: frueh verpackungstechnik ag release to warehouse date: 22.Feb.2019.Expiry date: 01.Feb.2029.Device was first manufactured unsterile under the lot 3l26861 in balsthal and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 292.620 with lot 3l26861 were reviewed: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material was confirmed to be correct per the specification with no non-conformance noted.Device is an instrument and is not implanted.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.

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.G4: the incorrect g4 date was inadvertently utilized in follow-up-1 medwatch.The correct date is july 10, 2019.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.

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.H10 additional narrative: h11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.Pec and pc codes updated as this is a duplicate complaint.Refer to (b)(4).(this report is now non-reportable.) 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 Ø1.25 W/THREAD-TIP W/TROCAR L1
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8650513
• MDR Text Key: 146387736
• Report Number: 8030965-2019-64639
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 04/30/2019

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: 292.620S
• Device Lot Number: 3L51497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 07/12/2019; 07/12/2019; 07/22/2019
• Supplement Dates FDA Received: 07/12/2019; 07/12/2019; 07/23/2019
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: TRAUMA.; UNK - SCREWS: 3.5 MM CANNULATED.; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: 3.5 MM CANNULATED
• Patient Outcome(s): Required Intervention