MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM GUIDE WIRE 280MM WITH TROCAR TIP; WIRE, SURGICAL

Catalog Number 292.130.01

Device Problem Break (1069)

Patient Problems Paralysis (1997); No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, gender & weight not provided for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Unknown: device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an event in (b)(6) as follows: it was reported that the wire broke off in the patient.The surgeon inserted and re-inserted the k-wire a few times and then it eventually broke off.He could not get it removed.He tried to insert another k-wire for the screw placement but struggled with access again and then left it.The k-wire remains in the patient.This complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Awareness date of previous report (follow up 2) was reported as may 23, 2018 but should have been may 23, 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

Additional patient identifier: (b)(6).Update event description: additional product code: hty, initial reporter name and telephone: (b)(6).Date reported in mwr-(b)(4) was 3/2/2018.Correct date should be 2/7/2018.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 (b)(6) as follows: it was reported patient underwent a procedure to repair a dens fracture on (b)(6) 2018.During the procedure, surgeon inserted and re-inserted the kischner wire (k-wire) a few times and the wire eventually broke off.Surgeon was not able to remove the k-wire fragment.It was further reported the k-wire placement was not correct.The k-wire reportedly went through the spinal cord, rendering the patient a quadriplegic.

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.Complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.Product was not returned.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 (information or/and material), the investigation will be updated as applicable.Part number: 292.130.01.Synthes lot number: l554361.Release to warehouse date: 04.Sep.2017.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.

• Brand Name: 1.25MM GUIDE WIRE 280MM WITH TROCAR TIP
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7325239
• MDR Text Key: 102104464
• Report Number: 8030965-2018-51862
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319677
• UDI-Public: (01)07611819319677(10)L554361
• Combination Product (y/n): N
• PMA/PMN Number: PREAD
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.130.01
• Device Lot Number: L554361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR