MAUDE Adverse Event Report: DEPUY MITEK LLC US BIO-INTRAFIX MODHEXDRV 30MM; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	254641
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
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.Investigation summary: the complaint device was received and evaluated.Visual inspection reveals rust deposits are evident on the device, therefore the reported complaint condition can be confirmed.The root cause for this failure can be attributed to the sterilization and/or cleaning of the device.Additionally, if not dried properly, this could cause corrosion.The cleaning instructions are noted in the instructions for use (ifu) and if not followed, this could cause corrosion.As the potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.Udi:(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that rust deposits were found in the cannulation of the following devices: 4 of 30mm modular driver - biocomposite, 1 of modular hex driver, 23 mm, 1 of modular hex driver 30 mm, 1 of ratchet handle w/jacob's chk.No patient involvement.

• Brand Name: BIO-INTRAFIX MODHEXDRV 30MM
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9555833
• Report Number: 1221934-2020-00048
• Device Sequence Number: 3096353
• Product Code: LXH
• UDI-Device Identifier: 10886705013333
• UDI-Public: 10886705013333
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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 Catalogue Number: 254641
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1