MAUDE Adverse Event Report: DEPUY MITEK LLC US MODULAR DRV 23MM; SURGICAL SCREWDRIVER, REUSABLE

Model Number	219957
Medical Device Problem Codes	Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the customer's 23mm modular drive was bent causing their 8 x 23mm milagro advance interference screw to crack.The screw was removed with no further issues.The procedure was completed with other devices using the same bone hole with no patient harm but there was a two minute surgical delay to the case to grab a new driver and screw.The sales rep was not present for the case therefore could not provide any further information.The devices will be returning for evaluation.
Additional 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.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.According to the information provided, it was reported that during an acl procedure the customer's 23mm modular drive was bent causing their 8 x 23mm milagro advance interference screw to crack.The screw was removed with no further issues.The complaint device was received and evaluated.Marks on the distal part of the device were observed during the visual inspection, it was also noted that the modular drive it¿s bent, which confirms the customer complaint.The root cause of the marks and the bent condition can be attributed to the use of the device since this is a reusable part.In addition, this type of failure may be related when the metal from an excessive of wear begins to lose the shape.However, it cannot be conclusively affirmed.  a manufacturing record evaluation was performed for the finished device lot number 1503001, and no non-conformances were identified at this point, 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.Udi: (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.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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR DRV 23MM
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9590714
• Report Number: 1221934-2020-00201
• Device Sequence Number: 492045
• Product Code: LXH
• UDI-Device Identifier: 10886705007004
• UDI-Public: 10886705007004
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

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 Model Number: 219957
• Device Catalogue Number: 219957
• Device Lot Number: 1503001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 03/06/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/18/2020; 03/06/2020
• Patient Sequence Number: 1