MAUDE Adverse Event Report: SYNTHES GMBH ROD CUTTER; CUTTER, WIRE

Catalog Number 388.720

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Part number: 388.720.Lot number: t197214.Manufacturing site: (b)(4).Release to warehouse date: may 19, 2020 (58 devices), june 5, 2020 (11 devices).A review of the device history records was performed for the finished device lot number and a non-conformance (nc) was started because small pores were visible in the weld seam on a few devices and were reworked.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.The raw material certificate was reviewed and the used material was according to the specification of the device.The bolt cutter (part # 388.720 and lot # t197214) was received at us customer quality (cq).Upon visual inspection, the cutter blade was observed to be broken.No other issues were identified with the returned device.Device failure/defect identified? yes.The dimensional inspection was not performed due to the post -manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) rod cutter.Complaint confirmed? yes.The complaint condition was confirmed for the bolt cutter.No definitive root-cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during a procedure the edge of the rod cutter was damaged after cutting 6.0 rods.There was no patient involvement.This report involves one (1) rod cutter.This is report 1 of 1 for (b)(4).

• Brand Name: ROD CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11974933
• MDR Text Key: 255440549
• Report Number: 8030965-2021-04762
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819710504
• UDI-Public: (01)07611819710504
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: T197214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - RODS