MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø16 FLEX CANN F/QUICK COUP F/D; BIT, DRILL

Catalog Number	03.037.002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Death
Event or Problem Description
Device report from synthes reports an event in israel as follows: on (b)(6) 2023, an operation to repair a femoral neck fracture was performed in a 75-year-old patient with a background of lung cancer and brain metastasis.During the surgery, among other things, the tfna system in hospital's possession was used, which includes, among other things, a multi-use hollow drill device sku 03.037.002.The use was made in combination with a guide wire sku 357.399 reprocessed.During the procedure, the guide wire, which is intended for the conduction of the hollow drill into the medullary canal, in the proximal part of the hip (by being inserted into the proximal part of the hip in such a way that part of it remains outside the bone), lodged into the femur, into the distal area of the femur (into the canal).According to the surgeon, he tried in different ways and by different means to release the guide wire from the distal part of the femur, but after about two hours he was asked by the anesthesiologist to stop the attempts due to the deterioration of the patient's condition.The patient died on the operating table.An autopsy was not performed after death and therefore the cause of death is unknown, however, and assumption was raised that the patient died as a result of a pulmonary embolism.Also, this cannot be dissociated completely from the device because of the guide wire becoming ¿lodged into the femur¿ and it being difficult ¿to release¿ from the distal part of the femur¿ which may have increased the surgical duration.Mso indicated that the co-morbidities (lung cancer and brain metastasis) and the hip fracture lower extremity procedure were both well recognized causes/contributors that increase the likelihood of pulmonary embolism, which is the suspected, but unverified cause of intraoperative death.There was surgical delay due to the reported event.The procedure was not successfully completed.There were patient outcome/consequences.Patient died.This report is for one (1) drill bit ø16 flex cann f/quick coup f/d this is report 2 of 2 for complaint (b)(4).
Additional 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.
Additional 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 03.037.002.Lot no: 4l00190.Release to warehouse:16 april 2019.Manufacturing site: werk bettlach.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 there were no damage or defect with the drill bit ø16 flex cann f/quick coup f/d, only was observed signs of normal wear.A dimensional inspection was performed for the drill bit ø16 flex cann f/quick coup f/d and met specifications.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 drill bit ø16 flex cann f/quick coup f/d was found to have no damage or defects.No definitive root cause could be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø16 FLEX CANN F/QUICK COUP F/D
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16765355
• Report Number: 8030965-2023-04866
• Device Sequence Number: 6105640
• Product Code: HTW
• UDI-Device Identifier: 07611819642294
• UDI-Public: (01)07611819642294
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.037.002
• Device Lot Number: 4L00190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø3.2 L400.
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 75 YR
• Patient Sex: Male