MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PELVIS PIN; PLATE, FIXATION, BONE

Catalog Number	71366302
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported two pelvic pins were used in iliac crest with the leg length device bent as they were used for the first time both from same batch.Results in measurement being compromised.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, several attempts have been made to obtain clinical/medical documents to no avail. without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: PELVIS PIN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7653697
• Report Number: 1020279-2018-01245
• Device Sequence Number: 18863430
• Product Code: HRS
• UDI-Device Identifier: 03596010425638
• UDI-Public: 03596010425638
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71366302
• Device Lot Number: 17JM20246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/30/2018
• Supplement Report FDA Received Date: 10/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other