MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 13X10X10MM; BONE STAPLE

Model Number	SE-1310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 an open reduction internal fixation (orif) of the tibia medial malleolus surgery using the bme continuous compression implants (cci) speed compression implant kit.The cci implant came off the insertion handle when inserting into the distal tibia.The surgeon tried to re-assemble onto insertion handle with lamina spreader, however, it does not work.The surgeon inserted a cci implant into the bone with lamina spreader holding implant legs apart.On final bone reduction evaluation, the fracture was not aligned properly.The cci implant was removed.Fracture re-reduced.Another cci implant of the same size was used without incident maintaining perfect reduction.The procedure was successfully completed with a five (5) minutes surgical delay.The patient outcome as planned.Concomitant device reported: unknown lamina spreader (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) speed compression implant kit 13 x 10 x 10mm.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: e4: exp.Date.H3, h6: device history lot part number: se-1310 bme lot number: bse170951 manufacturing date or release to warehouse date: (b)(6) 2018 place of manufacture: biomedical enterprises, san antonio, tx lot expiration date: (b)(6) 2022 dhr review: a review of the device history record for lot# bse170951 was performed and there were no non conformance's or manufacturing irregularities identified during the manufacture of this product or any subcomponents, which would contribute to this complaint condition.Device history batch null, device history review this lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture thcorrective 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initialat would contribute to this complaint condition.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SPEED COMPRESSION IMPLANT KIT 13X10X10MM
• 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: 8932503
• Report Number: 2939274-2019-60097
• Device Sequence Number: 13513677
• Product Code: JDR
• UDI-Device Identifier: 00810633020142
• UDI-Public: (01)00810633020142
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: SE-1310
• Device Catalogue Number: SE-1310
• Device Lot Number: BSE170951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1