MAUDE Adverse Event Report: SYNTHES GMBH DRILLSL YELL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.037.018

Device Problem Mechanical Jam (2983)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Device report from germany reports an event as follows: it was reported that on unknown date, some instruments were defective; they were jammed together.There was no patient involvement.Upon manufacturer investigation, it was determined that: the distal prong of the guide sleeve yell was bent.Additionally, signs of deformation were found at the proximal end of the device, where the mating device is assembled.The drillsl yell has one of the color markings missing.Additionally, the tab of the proximal section of the device was found bent outwards.The shaft of the trocar yell was found slightly bent.This report is for a drillsl yell.This is report 2 of 3 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.H10 additional narrative: b3: date of event is an unknown date in 2023.E3: reporter is a synthes employee.H3, h6: part: 03.037.018.Lot: 3l42238.Release to warehouse date:12 march 2019.Manufacturing site: werk hägendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 drillsl yell has one of the color markings missing.Additionally, the tab of the proximal section of the device was found bent outwards.No other defects were observed.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test performed with the returned mating device (guide sleeve yell) revealed signs of resistance and friction during the assembling and disassembling process, most likely due to the observed condition of the drillsl yell.However the reported jammed condition was not able to be replicated.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and excessive forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the drillsl yell would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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: DRILLSL YELL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18691308
• MDR Text Key: 336400594
• Report Number: 8030965-2024-02271
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.018
• Device Lot Number: 3L42238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• 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
• Treatment: GUIDE SLEEVE YELL; TFNA HELICAL-BLADE IMPACT; TROCAR YELL