MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 03.043.028

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.E3: reporter is a j&j employee.H3, h6: a product investigation was conducted.The product was returned to depuy synthese and sent to r&d for evaluation.The r&d team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on driving cap.It was observed that the cross pin connecting the pull button to the driving cap assembly fell apart, the pin was not returned.The observed condition of the pin has been previously assessed by materials and testing.Materials and testing provided drafted report that showed some deficiencies in the weld.Conclusion from r&d was that although the weld might not be perfect there must be some significant load leading to the failure of the weld.Materials and testing subsequently performed a finite element analysis to investigate origin of stress at the interface between cross pin and pull button.Analysis showed that strong off axis hammer blows can lead to oscillations in the system that can cause stress that can lead to breakage of the laser weld at the end of the pin and subsequent migration.Surgical technique guide mentions ¿apply light and controlled hammer blows to seat the nail¿ and ¿the hammer guide may aid in controlling the direction of the hammer blows.Therefore, the hammer guide can be attached to the back end of the driving cap by screwing both parts together¿.The dimensional inspection for the driving cap was not performed as it is not applicable to the complaint condition.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the driving cap.Based on the testing performed by materials and testing, the root cause can be determined to be traced to the user.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.H3, h4, h6: device history record (dhr) review conducted: part# 03.043.028 lot # 20253902 manufacturing site: werk selzach logistik release to warehouse date: 26 nov 2020 supplier: bächler feintech ag expiration date: n/a a manufacturing record evaluation was performed for the finished article lot and no non-conformance's 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 Description

It was reported that on an unknown date, upon routine inspection while restocking the instrument tray the consultant noticed that driving cap was damaged.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the cross pin connecting the pull button to the driving cap assembly fell apart, the pin was not returned.This report is for one (1) driving cap this is report 1 of 1 for complaint (b)(4).

• Brand Name: DRIVING CAP
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16865224
• MDR Text Key: 314765230
• Report Number: 8030965-2023-05711
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982297389
• UDI-Public: (01)10886982297389
• 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

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
• Device Operator: Health Professional
• Device Model Number: 03.043.028
• Device Catalogue Number: 03.043.028
• Device Lot Number: 20253902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• 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