MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.033.270S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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: 04.033.270s-us, lot: l984217, manufacturing site: (b)(4), release to warehouse date: 13 august 2018, expiration date: 31 july 2028.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 (b)(6) 2021, the patient underwent for a surgery.During the surgery, while attempting to insert recon screws into an unknown femoral recon nail (frn), the surgeon hit the nail with the drill bit.The nail was unstable because the surgeon did not pin both trocars before removing guide wire to drill the first hole.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This complaint involves an unknown number of devices.This report is for (1) 12mm / ti cann frn / gt 400mm / right - sterile.This report is 1 of 10 of (b)(4).

• Brand Name: 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12641953
• MDR Text Key: 277722785
• Report Number: 2939274-2021-06131
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271815
• UDI-Public: (01)10886982271815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.033.270S
• Device Catalogue Number: 04.033.270S
• Device Lot Number: L984217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 87