MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBIALSHEATH 30MM *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4).The expiration date is not currently available.Associated medwatches: 1221934-2018-51189 and 1221934-2018-51191.
Event or Problem Description
Postoperative pain.This is a legal case.The patient accepted unknown procedure in 2007.No anomalies were observed during at that time.After several years patient felt pain and doubted quality of implant.Then patient sued hospital and requested quality certification of device.Further information will be updated if available.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.The manufacturer contact name has been updated as (b)(6).Contact phone number and email address have been updated accordingly.The exp date was reported as unknown in the initial report and has been updated as 12/31/2049; therefore, udi: (b)(4).Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  a non-conformance search was performed for this product code 254601; lot #0607249 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7562211
• Report Number: 1221934-2018-51192
• Device Sequence Number: 19271198
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 254601
• Device Lot Number: 0607249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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