MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD 9MM *EA; BONENAIL GUIDEWIRE

Model Number	213709
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by affiliate via email, that pre-operatively to an acl procedure, potential problem was identified by hospital csd and an alternative set was used.Damaged instruments are: rigidfix femrod 9mm *ea (expands and cannot fit into guide frame), rigidfix fem b/t/b steptroc *ea (their one is barbed at the tip), rigidfix fem gdefr b/t/b *ea (screw has been cross threaded and will not go into guide).Devices are available.
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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported by affiliate via email, that pre-operatively to an acl procedure, potential problem was identified by hospital csd and an alternative set was used.Damaged instruments are: rigidfix femrod 9mm *ea (expands and cannot fit into guide frame), rigidfix fem b/t/b steptroc *ea (their one is barbed at the tip), rigidfix fem gdefr b/t/b *ea (screw has been cross threaded and will not go into guide).The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device not being returned, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10067456
• Report Number: 1221934-2020-01402
• Device Sequence Number: 11420347
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 213709
• Device Catalogue Number: 213709
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/11/2020
• Patient Sequence Number: 1