MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS; INSTRUMENT, CUTTING, ORTHOPAEDIC

Catalog Number 391.780

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that during an unknown procedure on (b)(6) 2019, the following instruments were found to have left spots on the pack.One (1) 13mm handle for bolt cutting head.One (1) 6mm socket wrench with straight handle.One (1) 24mm handle for bolt cutting head.Two (2) 11mm socket wrench with straight handle.Two (2) 11mm socket wrench cannulated for uss fracture clamps.One (1) cancellous bone impactor straight.One (1) cancellous bone impactor curve.The customer complained that after sterilization, these instruments stained the packaging they use to protect the cable during sterilization.They also report that the cable material is porous.The cleaning was manual, with enzymatic detergent and sterilization in the steam autoclave.The issue was noticed when the kit was opened while the patient was in the anesthetization room.The surgeon did not use these tools and requested competitor devices.Procedure was completed successfully with an unknown delay.Patient status is unknown.This report is for a bolt cutter handle.This is report 1 of 4 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.Part: 391.780; lot: 2024633.Per dhr files, actual device has component lot# 2024633 etched on it - top level lot is 4489834 or 4477099.Part: 391.780; synthes lot: 4477099; supplier lot: 2026805; actual device has component lot 2024633 etched on it; manufactured by supplier mathys medical ltd.; released to warehouse date: september 18, 2002.No nonconformance reports (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.Part: 391.780; synthes lot: 4489834; supplier lot: 2026805; actual device has component lot 2024633 etched on it; manufactured by supplier mathys medical ltd.; released to warehouse date: october 12, 2002.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.Visual inspection: visual inspection performed at customer quality (cq) of the complaint device in complaint file attachment confirmed the condition of foreign substance next to the device.The photos show a brown substance on the paper next to the phenolic handle instrument.The actual device was returned to cq, however no foreign substance was observed on the device.It is possible that the sterilization/decontamination process at monument has removed any evidence of the brown substance.The received image condition agrees with the complaint description.The complaint in not confirmed.We cannot definitively confirm that the stain originated from the complaint device as the returned device is not leaching any brown residue.Specification review: top level drawing.Top level drawing.Handle component drawing.Handle component drawing.Synthes recommends to follow the available reprocessing instructions to avoid possible problems.As part of our aspiration to offer the best quality products to our clients, in 2013, synthes initiated a program to replace the canevasit/phenolic handles of all instruments sold with either medical grade silicone rubber or polyphenylsulfone (ppsu).A dimensional inspection is not relevant for this complaint condition.Investigation conclusion: a definitive assignable root cause for the reported condition could not be determined based on the provided information.This complaint is confirmed for photo showing staining but not confirmed for the stains originating from the complaint device or how the stains occurred.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS
• Type of Device: INSTRUMENT, CUTTING, ORTHOPAEDIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8514001
• MDR Text Key: 142067629
• Report Number: 8030965-2019-62803
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 07611819024700
• UDI-Public: (01)07611819024700
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.780
• Device Lot Number: 2024633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1