MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRFX ADV -MOD HEX DRIVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	254836
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.Udi: (b)(4)¿ incomplete.The expiration date is not currently available.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure when inserting a 10x30mm screw the tip of their intrafix advance modular hex driver broke off in the head of the screw on the last turn.The tip was unable to be retrieved due to it being lodged tight within the screw.The sales rep stated that the surgeon was fine with it has he stated it would not go anywhere.The procedure had been completed with the device with no harm to the patient or delays to the case.The other part of the device will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Product complaint # (b)(4).Investigation summary: the complaint device was received and inspected.The complaint was confirmed.It was observed that the distal tip of the hex driver had been sheared off.The distal tip was also twisted.It is possible that the bone hole/screw interaction was abnormally tight causing excessive torque on the device tip therefore causing it to break.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.Device history lot dhr review: part number: 254836, supplier lot number: 1706001, qty of lot: (b)(4), release to warehouse date: 9/26/17, manufacturing date: 9/14/17, expiration date: n/a, supplier: (b)(4), manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INTRFX ADV -MOD HEX DRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 2400 ; CH 2400
• MDR Report Key: 7658516
• Report Number: 1221934-2018-52849
• Device Sequence Number: 16189036
• Product Code: LXH
• UDI-Device Identifier: 10886705026296
• UDI-Public: 10886705026296
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2018

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 254836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 07/30/2018; 11/30/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/31/2018; 07/31/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other