MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø7X280 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1830-0728S

Device Problems Break (1069); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Pharmacist reported that: "the operating block placed this morning a humeral nail t2, ref# 1830-0728s.During installation the nail (ref# 1830-0728s ¿ lot k295422ra) broke on the extremity.".

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged event.The device inspection revealed the following: the received device was broken at the proximal end, both pegs were teared off from the base.The improper insertion signs were evident at the internal thread of the nail which shows that the target device was not assembled properly.The fracture surfaces show that the nail was broken due to excessive torsional force applied.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on the investigation the root cause was attributed to a user related issue.The failure was cause due to improper handling i.E.After improper alignment in between nail and target device excessive torsional force was applied.As a collateral finding it was verified during the dhr review [device history records] that the implant in question for the provided lot code was already expired more than 3 years ago although the device packaging was evidently marked with an id-label which clearly presents an expiry date 2017-04.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.

Event Description

Pharmacist reported that: "the operating block placed this morning a humeral nail t2, ref# (b)(4).During installation the nail (ref# (b)(4) ¿ lot k295422ra) broke on the extremity.".

Manufacturer Narrative

Please note corrections to sections d4 lot# and expiration date and h4.The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged event.The device inspection revealed the following: visual inspection: the received device was broken at the proximal end, both pegs were teared off from the base.The improper insertion signs were evident at the internal thread of the nail which shows that the target device was not assembled properly.The fracture surfaces show that the nail was broken due to excessive torsional force applied.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on the investigation the root cause was attributed to a user related issue.The failure was cause due to improper handling i.E.After improper alignment in between nail and target device excessive torsional force was applied.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.

Event Description

Pharmacist reported that: "the operating block placed this morning a humeral nail t2, ref#: (b)(4).During installation the nail ((b)(4) ¿ lot k295422ra) broke on the extremity.".

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X280 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10347443
• MDR Text Key: 203170310
• Report Number: 0009610622-2020-00412
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540201348
• UDI-Public: 04546540201348
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1830-0728S
• Device Catalogue Number: 18300728S
• Device Lot Number: K295422RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• 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