MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL; CUTTER, WIRE

Catalog Number 391.771

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during an unknown procedure, the nurse handled the instrument and discovered a small piece of the device was split from the instrument head.No further information provided.This report is for one (1) bolt cutter head for 5.0mm fixation pins xl.This is report 1 of 1 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.H3, h6: a product investigation was conducted.Visual inspection: the bolt cutting head ø5 long cutting-h 2 f/ (part # 391.771, lot # 3457392) was received at us cq with a portion of the distal tip broken off obliquely.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed due to post manufacturing damage.Document/specification review: the relevant drawing(s) was reviewed; conclusion: the complaint condition is confirmed for the bolt cutting head ø5 long cutting-h 2 f/ (part # 391.771, lot # 3457392) as a portion of the distal tip was broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 391.771, lot: 3457392, manufacturing site: hägendorf, release to warehouse date: 02.Jun.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 HEAD FOR 5.0MM FIXATION PINS XL
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10310391
• MDR Text Key: 199939531
• Report Number: 8030965-2020-05159
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819112216
• UDI-Public: (01)07611819112216
• 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: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.771
• Device Lot Number: 3457392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1