MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W 1UB II BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72201991
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the manufacturer: one 72201991 osteoraptor 2.3mm plla-ha anchor w ub ii #2 blue suture device returned.The complaint stated: "it was reported that when the package was opened, suture was loosen and anchor was not attached to shaft properly.The surgeon tried to use the device using guide, but suture was stuck and anchor could not be inserted.¿ there was one blue suture returned.The anchor is present.It is damaged.It has symptoms of off axis alignment.It is fractured at the proximal end where the insertion handle seats.Per ifu: ¿only use the appropriate drill bits and drill guides intended for use with the osteoraptor suture anchor or the implant may not be properly aligned.Establish and maintain axial alignment of the suture anchor to the drilled insertion site using the in-line drill guide.Insert the suture anchor with inserter into the proximal end of the in-line drill guide.¿ the ifu also states: ¿the ifu instructs inspection of the device prior to use and indicates return of the device if any observances are noted.As stated in the complaint, there was attempt to use the device after the defect was noted.The device has been removed from its packaging.It is impossible to evaluate the condition the device was found in since it has been altered.No root cause related to the manufacture of this device was determined.
Event or Problem Description
It was reported that when the package was opened, suture was loosen and anchor was not attached to shaft properly.The surgeon tried to use the device using guide, but suture was stuck and anchor could not be inserted.A fracture in the anchor was found in the sample evaluation.No patient injury or delay was reported.

• Brand Name: OSTEORAPTOR 2.3 W 1UB II BLUE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7560660
• Report Number: 1219602-2018-00686
• Device Sequence Number: 11265695
• Product Code: MAI
• UDI-Device Identifier: 03596010615527
• UDI-Public: (01)03596010615527(17)220403(10)50656551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: 72201991
• Device Catalogue Number: 72201991
• Device Lot Number: 50656551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1