MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT 620MM; REAMER

Catalog Number 352.044

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981); Illegible Information (4050)

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

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, while inspecting the instruments after going through the decontamination process, it was noticed that several instruments were damaged.The handle with quick coupling, small was worn.The plastic on the handle was cracked.The drive adaptor qc for 5.0 schanz screws is a quick connect for shanz pins.Where the quick connect goes into the drill, it is worn and unable to go into the drill.The 5.0mm flexible shaft was worn.The tip of the reamer shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.Another 5.0mm flexible shaft was damaged.The 5.0mm flexible shaft 620mm was worn.It was a long rear shaft, and the tip of the reamers shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.It is unknown when the damage occurred to these items.There was no patient involvement.This report involves one 5.0mm flexible shaft 620mm.This is report 3 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

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, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 5.0mm flexible shaft 620mm was deformed from the tip.This condition can attribute to the unable to assemble condition.No other defect was found.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The etching information over the surface of the device was read without problems.Additionally, the device presents a worn appearance, consistent with normal and repetitive use over a long period of time consistent as an end of life indicator for the device.A dimensional inspection was not performed for the 5.0mm flexible shaft 620mm as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 5.0mm flexible shaft 620mm would contribute to the complained device issue.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.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): part: 352.044, lot: 2l96238, manufacturing site: werk bettlach, supplier na, release to warehouse date: 11 jan 2019, expiration date: na.A manufacturing record evaluation was performed for the finished article lot 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: 5.0MM FLEXIBLE SHAFT 620MM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18427730
• MDR Text Key: 331890524
• Report Number: 8030965-2024-00059
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194138
• UDI-Public: (01)10886982194138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.044
• Device Lot Number: 2L96238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2019
• 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