MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM; PLATE, FIXATION, BONE

Catalog Number 02.112.082

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter telephone number is reported as (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported revision surgery occurred on (b)(6) 2020, due to device failure and non-union of the bone.The plate and six (6) 3.5 mm stainless steel cortex screws were removed during the revision.It is unknown what the patient was revised to.The original implantation of an lcp superior clavicle plate was implanted in the patient on an unknown date in 2018.It was determined the cortical screws backed out of the lcp plate by x-ray on an unknown date.It was reported that the screws were thought to have been implanted and tightened correctly in the original surgery.This is report 1 of 7 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11: b1, b5, h1, h6: the initial complaint was reviewed and found not reportable.Additional information was received indicating there was only one screw that migrated.The one migrated screw is captured on manufacturer repot number 8030965-2020-07396.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.

Event Description

The initial complaint was reviewed and found not reportable.Additional information was received indicating there was only one screw that migrated.The one migrated screw is captured on manufacturer repot number 8030965-2020-07396.

• Brand Name: 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10580343
• MDR Text Key: 208345853
• Report Number: 2939274-2020-04296
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819436824
• UDI-Public: (01)07611819436824
• Combination Product (y/n): N
• PMA/PMN Number: K111540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.112.082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Patient Outcome(s): Required Intervention