MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BRISTOW-LATARJET 40MM SCREW,TOP-HAT(1); LIGAMENT ANCHOR

Catalog Number	285122
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The lot number is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
This is report 2 of 2 for the same event.It was reported by the affiliate in (b)(4) that there was conversion of latarjet procedure to reverse shoulder arthroplasty.Revision performed because of pain and the glenoid screws had penetrated articulate surface and axillary nerve palsy persisting.Patient had had multiple shoulder surgeries previously prior to latarjet procedure, subsequently experienced persistent axillary nerve palsy post-operatively, and pain in shoulder joint.Shoulder joint became unstable.Latarjet screws and top hats (x 2 each) were removed and discarded.Delta xtend rsa was implanted.It was reported that the patient's bone quality was quite good.It was reported that the screws were well seated in bone and required some effort to remove.It was reported that the surgeon was not off-axis.It was reported that the patient was not young and experienced oa in her shoulder joint quite quickly due to abnormal joint movement, secondary to the axillary nerve palsy.It was reported that the glenoid screw/s became exposed.It was reported that the screws were removed, and a patient had a shoulder replacement performed.It was reported that all metal work removed.It was not reported if there was a delay in the procedure or if a spare device was available for use.The patient's status post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received from the affiliate on 12/04/2018 reporting that previous surgery was performed on (b)(6) 2016.
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 is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a device history record (dhr) review.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.Udi: (b)(4).The lot number is not available.

• Brand Name: BRISTOW-LATARJET 40MM SCREW,TOP-HAT(1)
• Common Device Name: LIGAMENT ANCHOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8148343
• Report Number: 1221934-2018-55631
• Device Sequence Number: 11094540
• Product Code: HWC
• UDI-Device Identifier: 10886705020676
• UDI-Public: 10886705020676
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2018

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: Health Professional
• Device Catalogue Number: 285122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 12/02/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/13/2018; 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 49 YR