MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02263000S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The hospital call to report the following event: when opening the box during the procedure the blister is completely damaged.Using another device to complete the procedure.Need to re-sterilize the surgical field.No patient impact.Surgical delay of 15min.
Event or Problem Description
The hospital call to report the following event: when opening the box during the procedure the blister is completely damaged.Using another device to complete the procedure.Need to re-sterilize the surgical field.No patient impact.Surgical delay of 15min.
Additional Manufacturer Narrative
Product inquiry states the reamer shaft, ao fitting bixcut ø8,0x448 mm (packaging) to be the subject product.No further associated product was reported.Review of the dhr revealed no deviations.The item was documented as faultless prior to distribution.A deviation due to incorrect packaging of the reamer shaft into the cardboard box could be excluded as the found damage shows traces of an impact or contact with another object.The device inspection revealed the following: we received an empty reamer shaft, ao fitting bixcut ø8,0x448 mm (packaging) for evaluation.After unpacking the cardboard box an empty blister packaging with a cracked short side becomes visible and fully stripped tyvek lid.Detailed inspection revealed the cardboard box itself to be in general good condition ; no punctured inner side wall of cardboard box could be verified.Furthermore, an image of the shipping box was requested but not provided.As known from a previous case of pierced blister due to transport damage signs of a punctured inner side wall would have been verified.However, a damage in original condition could not have been verified, which have been possible in this case and would have been best presented the reported case, due to the fact that the packaging was received in already opened condition and with missing device.As known from a similar case it could not be excluded that the blister dropped down during unboxing from a high height.Nevertheless, an exact root cause could not be determined in this case.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8124228
• Report Number: 0009610622-2018-01497
• Device Sequence Number: 1569510
• Product Code: LXH
• UDI-Device Identifier: 07613153281641
• UDI-Public: 07613153281641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 06/30/2023
• Device Catalogue Number: 02263000S
• Device Lot Number: K0692DD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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