MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM GUIDE WIRE 400MM; MISC ORTHO SURGICAL INSTR

Catalog Number 357.399S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

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, 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 history lot; sterile part; part: 357.399s; lot: 6l64271; manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: jan 27, 2020; expiry date: jan 1, 2030.Since there is no allegation against packing, or sterility dhr review is done for non-sterile part: non - sterile - part.Part: 357.399; lot: 34p5609; manufacturing site: (b)(4).21-oct-2020 by: (b)(4).A dhr review was not performed for this pi.This lot was manufactured by elmira.Please reassign this task to the correct group.On 22-oct-2020 by: (b)(6).Part number: 357.399; lot number: 34p5609; part manufacture date: dec 30, 2019; manufacturing location: (b)(4) part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.2mm guide wire 400mm product was processed through the normal manufacturing, and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material 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.Device history review: this lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for femoral proximal fracture (31a1) with the guide wire in question.During the surgery, after the surgeon inserted the guide wire, he tried to insert the blade by hammering.When the blade passed the nail, the surgeon confirmed by image intensifier that the guide wire penetrated the bone head.The surgeon removed the blade and pulled the guide wire about 2cm.The surgeon inserted the blade again, and the surgery was completed successfully with a thirty (30) minute surgical delay.No further information is available.Concomitant devices reported: unknown nail head elements: helical blade (part# unknown, lot# unknown, quantity 1).Unknown nails (part# unknown, lot# unknown, quantity 1); unknown impaction inst: hammer/mallet: tr (part# unknown, lot# unknown, quantity 1).This report is for one (1) 3.2mm guide wire 400mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.2MM GUIDE WIRE 400MM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10822755
• MDR Text Key: 217660825
• Report Number: 8030965-2020-08837
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819384194
• UDI-Public: (01)07611819384194
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 357.399S
• Device Lot Number: 6L64271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 YR