MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the device was received as jrz complaints lab for investigation.The device was visually inspected.The coupling on the distal end of the shaft were observed to be bent.Device failure/defect identified? yes.Dimensional inspection: due to post manufacturing damage, a dimensional inspection cannot be performed on this part.Document/specification review: coupling: current and manufactured revisions no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the prongs on the distal end of the shaft are observed to be bent.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 the (b)(6) as follows: it was reported that on an unknown date, when the instrument was opened in the theatre at the start of the case, it was noticed that the instrument was damaged.This report involves one (1) 5.0mm flexible shaft.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13497401
• MDR Text Key: 285396098
• Report Number: 8030965-2022-00767
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243668
• UDI-Public: (01)07611819243668
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 43P8252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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