MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW, T7, DIAM. 2.7X14MM; PLATE, FIXATION, BONE

Catalog Number 53-27214E

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2015

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Surgeon was implanting a variax 11 hole distal plate in patient (right hand) as the result of bone breakage suffered from an atv accident.There was a hand innovation distal radius plate that was proximal to the bone breakage where the variax plate was implanted.Upon implanting of screws to secure the variax plate, the 2.7 screws went 2/3rd's of the way in and the heads snapped off (5 + pcs) and another 2 or 3 screws were removed prior to breakage due to visible bending during attempted implantation.Surgical delay of over 1 hour - additional anesthesia administered as a result.

Manufacturer Narrative

The evaluation revealed the four broken and three deformed screws to be primary products.The other two screws show no damages; therefore they were classified as concomitant items.A review of the manufacturing and inspection documents (dhr) was not possible because the lot codes were not provided.During investigation no dimensional or visual manufacturing related issues were found.The breakage surfaces of the four broken screws show a rough and cliffy structure; marked with circular lines, indicating that the screws broke spontaneous in a brittle fracture due to a torsional overload during insertion.The three deformed screws show no cracks or significant damages on their threads.The exact reason why they got deformed could not be determined.According to the hcp it is possible that the screws hit the implanted temporary transfixation k-wires, visible on both provided x-rays.Additionally it was found that all returned non-locking screws were partly discolored.Discoloration is known from previous complaints: the discoloration is a result of multiple washing and sterilization cycles, most likely contributed by an aggressive cleaning agent, and a known reaction of the titanium alloy.The identification, dimension, function and stability of the implants are not influenced.The provided x-rays show also that a ¿xxl volar dr plate,stand, right (11 holes)¿ with catalog number #54-25426 was implanted.Originally this plate has a defined curvature along its axis; the visual plate has no curvature; therefore it can be assumed that the plate was bent prior to usage.The ifu and operative technique includes several warnings regarding screw insertion to prevent breakages and deformations (i.E.Screws should not be over-tightened during insertion; usage of drill guides; usage of taps in case of hard bone; axial pressure during screw insertion).Only 2.7mm screws shall be used for volar plates.Contouring or bending of an implant should be avoided where possible, because it may reduce the strength and can cause failure under load.Because no indication for any manufacturer related issues were found during the investigation the case is attributed to a user error.No nonconformity identified.

Event Description

Surgeon was implanting a variax 11 hole distal plate in patient (right hand) as the result of bone breakage suffered from an atv accident.There was a hand innovation distal radius plate that was proximal to the bone breakage where the variax plate was implanted.Upon implanting of screws to secure the variax plate, the 2.7 screws went 2/3rd's of the way in and the heads snapped off (5 + pcs) and another 2 or 3 screws were removed prior to breakage due to visible bending during attempted implantation.Surgical delay of over 1 hour - additional anesthesia administered as a result.

• Brand Name: BONE SCREW, T7, DIAM. 2.7X14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4925331
• MDR Text Key: 22513372
• Report Number: 0008010177-2015-00168
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-27214E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other