MAUDE Adverse Event Report: SYNTHES GMBH APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP; CUTTER, WIRE

Catalog Number	329.317
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hxq.A product investigation was conducted.Visual inspection: the applic-forceps f/rapidsorb cranial clamp (p/n: 329.317, lot #: a7pa46) was returned and received at us cq.Upon visual inspection, the distal portion of the push arm component was observed to be slightly broken and rust was observed on the upper jaw component.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.The overall functional test was not performed as the device was returned by itself.However, the push arm was observed to be broken which could have caused the complaint condition.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed for the (b)(6) (p/n: 02.118.401, lot # h771082).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: part: 329.317.Lot: a7pa46.Manufacturing site: (b)(4).Supplier: chr.Diener gmbh & co.Kg.Release to warehouse date: 23.Nov.2006.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that the instrument was delivered to sterilization unit with a note that it does work.No further information provided.During manufacturer's investigation of the returned device it was observed that the distal portion of the push arm component was slightly broken and rust was observed on the upper jaw component.This report is for one (1) application device for resorbable cranial clamp.This is report 1 of 1 for complaint (b)(4).

• Brand Name: APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11867173
• Report Number: 8030965-2021-04155
• Device Sequence Number: 3725191
• Product Code: HXZ
• UDI-Device Identifier: 07611819900479
• UDI-Public: (01)07611819900479
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 329.317
• Device Lot Number: A7PA46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1