MAUDE Adverse Event Report: SYNTHES GMBH STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.037.022

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Health effect- clinician code (b)(4) used to capture injury.Investigation summary: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned attachments.Visual analysis of the photo revealed that there was no damage or defects with the stepped ream f/tfna helic blade+scr f/dh.There is not enough evidence in the photo to confirm the allegation.No other problems were observed.Conclusion: the complaint condition is being confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 (b)(6) 2022, during a the trochanteric fixation nail - advanced (tfna) case, 356.830_0761819291355 was inserted into the femoral head, and drill bit stepped ream f/tfna helic blade+scr f/dh was guided into the 356.830 to drill.It was met with resistance halfway through.The surgeon tried to push in and continue with the drilling, but still met with resistance.An x-ray showed stepped ream f/tfna helic blade+scr f/dh was cutting on the guidewire ø3.2 f/pfna blade, and the guidewire ø3.2 f/pfna blade appear bent.Stepped ream f/tfna helic blade+scr f/dh was removed, and found no damage to the drill bit guidewire ø3.2 f/pfna blade was removed, and metal particles could be seen left inside the femoral head.Surgeon tried to flush out the metal particles, there were still metal particle left inside the femoral head.The surgeon change to another wire and continue with the surgery.No patient consequence was reported.Surgery was delayed 5 minutes due to reported issue.This report is for one (1) stepped ream f/tfna helic blade+scr f/dh.This is report 2 of 2 for complaint (b)(4).

• Brand Name: STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15077245
• MDR Text Key: 296336716
• Report Number: 8030965-2022-05064
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819642485
• UDI-Public: (01)07611819642485
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GUIDEWIRE Ø3.2 F/PFNA BLADE
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female