MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE CABLE PASSER-45 DEG ANGLE; MISC ORTHO SURGICAL INSTR

Catalog Number 391.108

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and 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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, an unknown surgery for the femoral trochanteric fracture was performed with two (2) cable passers.During the surgery, the surgeon could not thread the cables into the passers' hole.Subsequently, a blackish brown colored foreign material came out from the holes of passers.The surgeon suspected the insufficiency of the cleaning before the device was shipped.The surgery was delayed by less than 30 minutes.The surgery was completed successfully.There was no adverse consequence to the patient.Concomitant device: cable (part unknown, lot unknown, quantity 1).This report is for one (1) cable passer.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The review of the attached photos shows some black residues as reported in the complaint description.We are not able to identify the source of those residues.However, as the devices are several years old and seems to be often used, inadequate cleaning and maintenance after prior use may be root cause for the detected residues.Device history lot part number: 391.108 synthes lot number: p171468 supplier lot number: n/a release to warehouse date: 14-feb-2014 expiration date: n/a supplier: pioneer surgical technology manufactured by synthes no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.

• Brand Name: LARGE CABLE PASSER-45 DEG ANGLE
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8378861
• MDR Text Key: 137517084
• Report Number: 8030965-2019-61575
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819719781
• UDI-Public: (01)07611819719781
• 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
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.108
• Device Lot Number: P171468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1