MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: k120854.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part mfg date: 09-jun-2017 ; part exp.Date: n/a; manufacturing location: depuy synthes ¿ (b)(4); lot number: h380262; part number: 02.118.403.Dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot# h380262 of 2.7mm va-lcp lateral distal fibula plate/4 holes/left was processed through the normal manufacturing and inspection operations with no non-conformance or rework noted.This 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 was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the patient underwent hardware removal of one (1) variable angle locking compression plate (lcp) lateral distal fibula plate, one (1) lcp low bend medial distal tibia plate, five (5) 2.7 va locking screws, four (4) 3.5 cortex screws, one (1) 4.0 cannulated screw, four (4) 2.7 cortex screws, and five (5) variable angle (va) locking screws due to pain.The devices were originally implanted on (b)(6) 2017.All implants were removed successfully with no issues.It was unknown if there was a surgical delay.Patient and procedure outcome was unknown.This complaint involves seven devices totaling (21).This complaint is for (1) 2.7mm va-lcp lateral distal fibula plate.This report is 1 of 7 for (b)(4).
Additional Manufacturer Narrative
Updated description with explantation date.Corrected data: additional product code: hwc.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 an (b)(6) 2018 the patient underwent hardware removal of one (1) variable angle locking compression plate (lcp) lateral distal fibula plate, one (1) lcp low bend medial distal tibia plate, five (5) 2.7 va locking screws, four (4) 3.5 cortex screws, one (1) 4.0 cannulated screw, four (4) 2.7 cortex screws, and five (5) variable angle (va) locking screws due to pain.The patient will eventually need an ankle fusion.The devices were originally implanted on december 11, 2017.All implants were removed successfully with no issues.It was unknown if there was a surgical delay.Patient and procedure outcome was unknown.
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.Device history lot , part mfg date: 09-jun-2017 , part exp.Date: n/a, manufacturing location: depuy synthes ¿ elmira, lot number: h380262, part number: 02.118.403.Dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot# h380262 of 2.7mm va-lcp lateral distal fibula plate/4 holes/left was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This 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.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during 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: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
• 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: 7957210
• Report Number: 2939274-2018-54303
• Device Sequence Number: 11101601
• Product Code: HRS
• UDI-Device Identifier: 10886982038869
• UDI-Public: (01)10886982038869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.118.404
• Device Catalogue Number: 02.118.403
• Device Lot Number: H380262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 11/16/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 102