MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number	2030-6530-1
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
The head of a 30mm torx screw came off whilst it was being implanted.The screw body was implanted when the head broke.The exposed section of the screw was burred down, as not to protrude from the cup.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a hip screw intra-operatively was reported.The event was confirmed by visual inspection of the returned product.Method & results: device evaluation and results: one section of a screw was returned for evaluation.The screw was returned fractured.A review of the returned device by a material analysis engineer indicated: fracture observed on screw consistent with an overload condition.Based on the given information, no identifiable materials or manufacturing discrepanices were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the event reported that a 30mm torx screw fractured intra-operatively.One section of a screw was returned for evaluation.The screw was returned fractured.A review of the returned device by a material analysis engineer indicated: fracture observed on screw consistent with an overload condition.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The head of a 30mm torx screw came off whilst it was being implanted.The screw body was implanted when the head broke.The exposed section of the screw was burred down, as not to protrude from the cup.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7674929
• Report Number: 0002249697-2018-02111
• Device Sequence Number: 1370012
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 09/30/2022
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: 3T12VJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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
• Patient Age: 79 YR