MAUDE Adverse Event Report: SYNTHES GMBH LARGE QUICK COUPLING; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	338.49
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
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: d1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - screws: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.D2b: additional product code: d4: udi: (01)gtin unavailable, product made prior to gtin compliance date d6b: part of the screw remained in the patient¿s bone; device not considered explanted.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.D9: complainant part is not expected to be returned for manufacturer review/investigation.A1: patent identifier: e3: reporter is a j&j employee.E3: reporter is a j&j sales representative.G4: device is not distributed in the united states but is similar to device marketed in the usa.H6: health effect ¿ clinical code e2402 used to capture - h3, h4, h6: a review of the device history record has been requested.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.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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 or Problem Description
It was reported that on (b)(6) 2023, that the large quick coupling  got stuck in the female part of the power drill.There were no patient consequences or outcomes.This report is for one (1) large quick coupling this is report 1 of 1 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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 338.49, synthes lot # ma1080, supplier lot # ma1080, release to warehouse date: 16 oct 2012, supplier: (b)(4).No ncrs were generated during production.Service and repair evaluation: the customer reported that 338.49, large quick coupling was got stuck in female part of power drill.The repair technician reported device failed cosmetic test, device was dented and device will not be repaired.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is damaged component.The item will be forwarded to customer quality.The evaluation was confirmed.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LARGE QUICK COUPLING
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 18184622
• Report Number: 8030965-2023-14664
• Device Sequence Number: 15356351
• Product Code: FZX
• UDI-Device Identifier: 10886982193513
• UDI-Public: (01)10886982193513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 338.49
• Device Lot Number: MA1080
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2012
• 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: UNKNOWN DRILL BITS
• Patient Sex: Unknown