MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLTCUTTER; CUTTER,WIRE

Catalog Number 388.720

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales representative a review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes europe reports an event in argentina as follows: it was reported that on an unknown date, a bolt cutter was broke in the cutting area.It was unknown when the issue observed.It is unknown if there were patient and procedure involvement.This complaint involves one (1) device.This report is 1 of 1 for pc-(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.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

It was reported that on an unknown date, a bolt cutter was broken due to cutting of an unknown croco rods in the cutting area during an inspection before an unknown surgery.There was no procedure or patient involvement.Concomitant device reported: unknown croco rods (part# unknown, lot # unknown, quantity unknown).

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.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.Part: 388.72; synthes lot: t159279; release to warehouse date: december 13, 2017; manufacture site: tuttlingen; part expiration date: n/a no relevant nonconformance reports (ncrs) were generated during the production of this device.Further review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Visual inspection: device was not returned.Visual inspection of the provided photo in complaint file performed at customer quality (cq) confirmed the condition of breakage, which agrees with the reported complaint condition.Both distal cutting jaws have a portion of the cutting surface broken off.Device history record (dhr) review: review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.Document/specification review: rod/cutter design drawing was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Material analysis: the raw material certificate was reviewed and the used material was according to the specification of the device.Was the complaint confirmed? yes conclusion: a definitive root cause for the damage could not be determined based on the provided information.This complaint is confirmed however 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: BOLTCUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8120924
• MDR Text Key: 128952615
• Report Number: 8030965-2018-58653
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819710504
• UDI-Public: (01)07611819710504
• 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,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.720
• Device Lot Number: T159279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 01/08/2019; 01/10/2019
• Supplement Dates FDA Received: 01/08/2019; 01/09/2019; 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION