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

Model Number 03.607.513

Device Problem Break (1069)

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 a cable cutter broke during an unknown procedure on (b)(6) 2018.The cable cutter broke before it was used on the patient.The surgeon changed to another cable cutter to complete the procedure.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.This report is for one (1) cable cutter.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device history record (dhr) review: part: 03.607.513; lot: 9603630; manufacturing site: (b)(4); release to warehouse date: 24 september 2015.Only top level of the device history record reviewed as sub-components are not lot tracked.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 material was reviewed, and the hardness value was confirmed to meet the specification with no non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product 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: CABLE CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7906145
• MDR Text Key: 121714386
• Report Number: 8030965-2018-56624
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982080585
• UDI-Public: (01)10886982080585
• 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: 08/30/2018

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 Model Number: 03.607.513
• Device Catalogue Number: 03.607.513
• Device Lot Number: 9603630
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1