MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTRAFX SHEATH&SCRSYS,8MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254682
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The batch review 3445163 showed that the devices were conformed to in process and finished goods specifications when released to stock the 26 july 2010.Expiration date: 2013-07 (according to retained labels).No nc was opened.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.Capa has been opened to investigate this failure mode.No further action is warranted at this time.However, depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The sales rep reported that during an acl repair that his intrafix femoral screw 8 mm broke when it was 3/4 of the way inserted.The sales rep reported the tunnel size was 9 mm and the graft was 8 mm stating it as a tight fit.The surgeon then used the dilator and inserted the sheath and proceeded to insert the screw when it broke in half about 3/4 of the way in.The surgeon completed the procedure with another same device with no patient consequences or delay the sales rep stated the patient was a (b)(6)year old female with good bone quality.The sales rep did not know the preexisting medical conditions, medications or previous surgeries.The device was already discarded by the facility.

• Brand Name: FEM.INTRAFX SHEATH&SCRSYS,8MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7686254
• Report Number: 1221934-2018-51366
• Device Sequence Number: 11112205
• Product Code: MAI
• UDI-Device Identifier: 10886705013630
• UDI-Public: 10886705013630
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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
• Report Date (Section B): 07/29/2013

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: 07/01/2013
• Device Catalogue Number: 254682
• Device Lot Number: 3445163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2013
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR