MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 110MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.210S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id also reported as (b)(4).Additional procode: ktt.Manufacturing location: (b)(4).Release date: august 07, 2019, expiration date: june 30, 2029.Part: 04.038.210s, tfna fennestrated screw 110mm -sterile.Lot: 13l1169 (sterile).Note: blade was manufactured by elmira; lot number 11l5688.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The implant(s) was not returned and instead the investigation will be done based on the received image(s).The image(s) was reviewed, and the complaint condition could be confirmed as the image provided shows some rotation of the screw.As the implant(s) was not returned, an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.(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) 2020, patient underwent revision surgery due to cut-through of a trochanteric fixation nail advanced (tfna) fenestrated screw.Device was originally implanted on (b)(6) 2020.The tfna fenestrated screw appears to be intact without warping or any implant fragmentation but upon reviewing the x-ray from the implantation, it appears to be over-rotated.Procedure was completed successfully with no delay.Patient status was stable.This report is for a tfna fenestrated screw.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 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
Updated concomitant devices reported: titanium cannulated tfna-sterile (part 04.037.042s, lot 47p3301, quantity 1), titanium locking screw with t25 stardrive (part 04.005.528s, lot 53p7168, quantity 1).

• Brand Name: TFNA FENESTRATED SCREW 110MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10730310
• Report Number: 2939274-2020-04811
• Device Sequence Number: 11182324
• Product Code: HSB
• UDI-Device Identifier: 10886982098818
• UDI-Public: (01)10886982098818
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.210S
• Device Catalogue Number: 04.038.210S
• Device Lot Number: 13L1169
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 16MM CANNULATED HOLLOW DRILL BIT - STERILE; 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; 5.0MM TI LOCKING SCREW; 5.0MM TI LOCKING SCREW; TFNA FENESTRATED SCREW 110MM - STERILE; 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 16MM CANNULATED HOLLOW DRILL BIT - STERILE; 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; 5.0MM TI LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention