MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP T-FUSION PL 3 HOLE HEAD/EXTRA LONG; PLATE, FIXATION, BONE

Model Number	02.211.265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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, a patient underwent hardware removal of olecranon due to infection and inflammation.One (1) variable angle locking compression plate (va-lcp) titanium fusion plate 3 holes, one (1) locking compression plate 10 holes, 0ne (1) variable angle locking compression plate (va-lcp) olecranon plate 6 holes, two (2) cortical screws, one (1) locking screw, eight (8) variable angle locking screws, three (3) 2.7 cortex screws and two (2) cortex screws were removed.All hardware was intact.The original implant date was on (b)(6) 2018, with open reduction and internal fixation (orif) for a gunshot wound.There was no surgical delay.The procedure was successfully completed.Patient outcome was complete and stable.This is report 1 of 10 for (b)(4).This complaint is linked to (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 product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.4 / 2.7mm va-lcp t-fusion pl 3 hole head/extra long product was processed through the normal manufacturing and inspection operations with no rework or non-conformances 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 device history record.Device history lot.Part number: 02.211.265, lot number: h562598, part manufacture date: 12 feb 2018, 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 2.4 / 2.7mm va-lcp t-fusion pl 3 hole head/extra long product was processed through the normal manufacturing and inspection operations with no rework or non-conformances 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.Device history batch component.Part number: 14087, lot number: h500193, part manufacture date: 08-nov-2017, manufacturing location: elmira, part expiration date: n/a.Nonconformance noted: raw material part number 316l fi39.00x13.00 lot number h500193 was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review 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.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: 2.4/2.7MM VA-LCP T-FUSION PL 3 HOLE HEAD/EXTRA LONG
• 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: 9105034
• Report Number: 2939274-2019-60778
• Device Sequence Number: 16682331
• Product Code: HRS
• UDI-Device Identifier: 10886982054746
• UDI-Public: (01)10886982054746
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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): 08/27/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.211.265
• Device Catalogue Number: 02.211.265
• Device Lot Number: H562598
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 93