MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP® PLATE 9 HOLES/170MM; PLATE,FIXATION,BONE

Model Number	224.591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes hwc, ktt.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent removal of narrow locking compression plate (lcp) due to broken plate and replaced with a new large fragment plate.The surgeon performed the initial surgery on (b)(6) 2018 for a tibia and fibula fracture.He used narrow locking compression plate (lcp) along with four (4) locking screws and five (5) cortex screws.It is unknown if there was a surgical delay.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: unk - screws: locking: trauma (part # unknown, lot # unknown, quantity 4); unk - screws: cortex: trauma (part # unknown, lot # unknown, quantity 5).This report is for one (1) 4.5mm narrow lcp® plate 9 holes/170mm.This is report 1 of 1 for (b)(4).
Additional 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.Investigation summary updated event description: it was reported that on (b)(6) 2019, the patient underwent removal of narrow locking compression plate (lcp) due to broken plate and replaced with a new large fragment plate.The surgeon performed the initial surgery on (b)(6) 2018 for a tibia and fibula fracture.He used narrow locking compression plate (lcp) along with four (4) locking screws and five (5) cortex screws.It is unknown if there was a surgical delay.Procedure was successfully completed.Patient status is unknown.The implant was not returned and instead will be do based on the supplied image labeled: intake email received from sales consultant 27 feb 2019.The image(s) (1 total) was reviewed and the complaint condition for broken could be confirmed as the image(s) showed that it broke along the fifth combi hole.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 224.591, lot number: 7457566, part manufacture date: 19-aug-2013, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm narrow lcp plate 9 holes/170mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review that would contribute to this complaint condition.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.

• Brand Name: 4.5MM NARROW LCP® PLATE 9 HOLES/170MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8440443
• Report Number: 2939274-2019-57070
• Device Sequence Number: 16875508
• Product Code: HRS
• UDI-Device Identifier: 10886982158529
• UDI-Public: (01)10886982158529
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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 Model Number: 224.591
• Device Catalogue Number: 224.591
• Device Lot Number: 7457566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention