MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP MODULAR MINI FRAGMENT INSTRUMENT AND IMPLANT SET; TRAY,SURGICAL INSTRUMENT

Catalog Number 01.111.120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown - kits/sets/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Device evaluated by mfr, manufacture date: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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

It was reported on (b)(6) 2019, the mini fragment or anterior clavicle plate for the case # (b)(4) was not there.A delivery not arriving at (b)(6).What was supposed to happen that the (b)(4) are transferred to (b)(6) case # (b)(4).The perceived issue was the (b)(4) were not transferred to (b)(6) for case # (b)(4).Field stocking location (fsl) specialist determined that (b)(4) was in quarantined status at fsl and (b)(4) was in receiving at fsl.  as of 11:48 am, the sales consultant (sc) is running a borrowed mini fragment to (b)(6) for the 2:15 pm case.Fsl spoke with the sc at 4pm and confirmed he did not have enough time to get the borrowed mini fragment to (b)(6) in time for surgery.The sc said they made do for the case, but there was impact due to the surgical plan needing to be changed.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 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.Patient code 3191 used in intial medwatch report to capture change in surgical plan.Complainant part is not expected to be returned for manufacturer review/investigation.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

Further it was reported that the reserved fsl sets (mini frag and ant clavicle) were not delivered to the facility like they were supposed to be.There is nothing wrong with the sets.The issue was reported because the doctor had to change the surgical plan due to the mini frag and ant clavicle not being in the room for surgery.This report is for lcp modular mini fragment instrument and implant set.

• Brand Name: LCP MODULAR MINI FRAGMENT INSTRUMENT AND IMPLANT SET
• Type of Device: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8843918
• MDR Text Key: 152787104
• Report Number: 2939274-2019-59465
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.111.120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention