MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST 8; STAPLE, FIXATION, BONE

Model Number SE-2020-08

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 history lot: no ncrs were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 Description

It was reported that on an (b)(6) 2021, patient underwent a surgical procedure.Implant was deployed off, prior to being inserted into the bone and the implant fell on the floor.Thus the same implant could not be used and an additional implant of the same size was used in its place.The implant was not recovered, and cannot be returned.Procedure was completed successfully without any surgical delay.Concomitant device reported: unk: drill (part# unknown; lot# unknown; quantity: 1).This report is for one (1) speed shift 20x20x20 offset 08mm implant.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST 8
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12512238
• MDR Text Key: 272682632
• Report Number: 2939274-2021-05690
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020487
• UDI-Public: (01)00810633020487
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: SE-2020-08
• Device Catalogue Number: SE-2020-08
• Device Lot Number: BSE180174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK: DRILL BITS: TRAUMA
• Patient Age: 15 YR