MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE

Catalog Number 356.830S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Expiration date is unknown.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.(b)(4).The guide broke intraoperatively and a fragment remained in the patient's bone.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 the patient underwent an open reduction internal fixation (orif) with antegrade femoral nail (afn) (b)(6) system due to a femoral diaphyseal fracture on (b)(6) 2018.During the procedure, when the surgeon inserted the guide wire for a side stopping under recon locking mode, the tip of the guide wire was broken and remained in the patient's bone.Additionally, the surgeon had moved and reinserted the guide wire several times in the bone for adjustment.Then, the surgeon changed the way of side stopping from recon locking mode to standard locking mode.The procedure was successfully completed with no surgical delay, but the broken piece was left in the bone.There was no additional treatment scheduled.Patient status was good.Concomitant device: unknown afn nail (part# unknown, lot# unknown, quantity 1) and unknown afn screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is 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.A device history record (dhr) review was conducted: please note, this dhr review is for sterilization procedure only: part no.: 356.830s, lot no.: 1l56788, manufacturing location: selzach, supplier: (b)(4).Release to warehouse date: 20.Sep.2018, expiry date: 01.Sep.2028, non-sterile 356.830 / 1l18776 was manufactured in balsthal, release to warehouse date: 23.Aug.2018.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate l904699 was reviewed and the used material was according to 316l specification for this guide wire.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 is an instrument and is not implanted; as such implant date is not 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.

• Brand Name: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Type of Device: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8249918
• MDR Text Key: 133267555
• Report Number: 8030965-2019-59900
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819898073
• UDI-Public: (01)07611819898073
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.830S
• Device Lot Number: 1L56788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 48