MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS; BONE STAPLE

Model Number	EL-1515S2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot: part number: el-1515s2.Bme lot number: bel180570.Manufacturing date or release to warehouse date: 16-july-2019.Place of manufacture: (b)(4).Lot expiration date: 8-june-2023.Dhr review: no ncmrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which 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 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent an unknown procedure.It was mentioned that the biomedical enterprise (bme) elite compression implant was misfired and a new one had to be used.The case went fine.The procedure was successfully completed with a three (3) minutes surgical delay.The patient status is unknown.This report is for one (1) elite compression implant kit 15 x 15 x 15 mm 2 legs.This is report 1 of 1 for (b)(4).

• Brand Name: ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS
• 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: 8969986
• Report Number: 2939274-2019-60358
• Device Sequence Number: 19476881
• Product Code: JDR
• UDI-Device Identifier: 00810633021675
• UDI-Public: (01)00810633021675
• Combination Product (Y/N): N
• PMA/510(K) Number: K150125
• 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
• Report Date (Section B): 08/09/2019

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: 06/08/2023
• Device Model Number: EL-1515S2
• Device Catalogue Number: EL-1515S2
• Device Lot Number: BEL180570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 54