MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HA PIN {} 6MM {} 35MM X 150MM; PIN, FIXATION, THREADED

Catalog Number	71070806
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).E1,g2: this event was extracted from a retrospective review of clinical data that was intentionally anonymized by a third-party vendor before being provided to our firm.As a result, it is not possible to determine the specific healthcare facility where the event occurred.H6: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, a patient who initially underwent placement of a taylor spatial frame (tsf) on (b)(6) 2016 to treat an open tibia fracture and bone grafting subsequently developed nonunion on (b)(6) 2016.The patient was unable to tolerate prior attempts at treatment for his nonunion and was inconsistent with his ability to follow up or care for himself.Considering he had also severe deformity of the left foot from prior trauma, amputation of the left lower extremity was recommended.No further information is available.

• Brand Name: HA PIN {} 6MM {} 35MM X 150MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21441858
• Report Number: 1020279-2025-00325
• Device Sequence Number: 14623531
• Product Code: JDW
• UDI-Device Identifier: 03596010495549
• UDI-Public: 3596010495549
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2025

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?: No
• Device Catalogue Number: 71070806
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71070320 / LOT: UNKNOWN.; PN: 71070340 / LOT: UNKNOWN.; PN: 71070802 / LOT: UNKNOWN.; PN: 71070808 / LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male