MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 09X07X07MM; BONE STAPLE

Model Number	SE-0907
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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) 2018, a proximal interphalangeal (pip) joint fusion surgery of the fifth finger was performed.The surgeon attempted to fuse the proximal enter fell and jill joint of the fifth metacarpal on the right-hand side of the patient.The surgeon was going to use the 20907 staples to fuse the joint but, when the staples were removed from the packaging, they had disengaged from the inserter and were not able to be used for the procedure.Another staple of the same size was then used to hold a reduction and the surgeon then decided to remove the staple and use 2k wires to complete the surgery.There was a five-minute surgical delay.Patient and surgical outcome are unknown.This report is for one (1) speed compression implant kit 09x07x07mm.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.Device history lot part number: se-0907, bme lot number: bbse170504, manufacturing date or release to warehouse date: 26 sep 2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 25 jul 2022.Dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of staples 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.The review of the raw material device history record revealed two nonconformance to be associated to raw material lot 120-e700.Ncmr was generated due to fifteen (15) implants with edm marks and pitting found during visual inspection.Ncmr was generated due to the lot being short one (1) implant.Lot 120-e700 was released as conforming as all nonconforming parts were scrapped.The nonconformance is not relevant to the complaint because a lost implant or cosmetic appearance of the raw material would not contribute to the inserter deploying the implant prematurely.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented 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: SPEED COMPRESSION IMPLANT KIT 09X07X07MM
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7953557
• Report Number: 2939274-2018-54291
• Device Sequence Number: 19108695
• Product Code: JDR
• UDI-Device Identifier: 00810633020104
• UDI-Public: (01)00810633020104
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Expiration Date: 07/25/2022
• Device Model Number: SE-0907
• Device Catalogue Number: SE-0907
• Device Lot Number: BSE170504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention