MAUDE Adverse Event Report: GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.111.600
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the sterile process the reduction forceps points broad-ratchet tip was found broken, t15 cann strdrv scrwdrvr sft slf-retain was striped, & guide block for 2 colm pl 6 hole head/rt holes were not smooth for drop-in guide.The holes do not line up with the plates anymore.No patient involvement.This report is for one (1) guide block for 2 colm pl 6 hole head/rt.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.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.The device was not returned.Upon inspecting all the images provided under notes & attachments section, the allegation unable to assemble can not be confirmed for the guide block for 2 colm pl 6 hole head/rt.The functionality test can't be performed as only photo is received.The complaint condition can't be 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 history lot - part # 03.111.600.Lot # 10-5546.Manufacturing site: (b)(6).Release to warehouse date: (b)(6) 2010.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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.

• Brand Name: GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• MDR Report Key: 12594449
• Report Number: 2939274-2021-05959
• Device Sequence Number: 19948276
• Product Code: FZX
• UDI-Device Identifier: 10886982072467
• UDI-Public: (01)10886982072467
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2021

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 Model Number: 03.111.600
• Device Catalogue Number: 03.111.600
• Device Lot Number: 10-5546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 10/12/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/12/2021; 11/04/2021
• Date Device Manufactured: 08/17/2010
• 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: REDUCTION FORCEPS POINTS BROAD-RATCHET.; T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN.